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idK180886_s2000_e4000

K180886.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

/mL. Colony counts was also determined from one replicate of each reproducibility isolate on each of the three days of testing and from a minimum of 10% of the clinical strains tested. d. Detection limit: Not Applicable e. Analytical specificity: Not Applicable f. Assay cut-off: Not Applicable 2. Comparison studies: a. Method comparison with predicate device: Results obtained with Liofilchem MIC Test Strip (MTS) with Delafloxacin were compared to results obtained from frozen reference MIC panels. Reference panels were prepared and interpreted as outlined in the recommendations in CLSI document M7-A10. Isolated colonies from an overnight blood agar plate were suspended in saline to achieve a 0.5 McFarland standard turbidity (approximately 108 CFU/mL). Testing conditions consisted of incubation of the inoculated Mueller Hinton agar plates in and 7 inverted position at 35°C ±2 for 16-20 hours. At the end of incubation, the MIC value where the edge of the inhibition ellipse intersects the strip was compared to the reference method. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Delafloxacin was 100% Clinical: Clinical testing was performed at three US sites. A total of 360 clinical isolates were tested which included 240 Enterobacteriaceae isolates (15 K. aerogenes, 45 E. cloacae, 90 E. coli, 15 K. oxytoca, 60 K. pneumoniae, 15 P. mirabilis) and 120 P. aeruginosa. 65.6% of the clinical isolates were collected within 6 months of isolation. Challenge: Challenge testing was performed at one internal site. A total of 88 challenge isolates were tested which included 68 Enterobacteriaceae isolates (5 K. aerogenes, 14 E. cloacae, 21 E. coli, 5 K. oxytoca, 20 K. pneumoniae, 3 P. mirabilis) and 20 P. aeruginosa isolates. The total of 448 clinical and challenge isolates is summarized in Table 3 below. Table 3: Overall Performance of Clinical and Challenge Isolates (Combined) Delafloxacin EA Tot EA N EA % Eval. EA Tot Eval. EA N Eval. EA% CA N CA % #R min maj vmj Enterobacteriaceae (all) Clinical 240 237 98.8 230 227 98.7 236 98.3 60 4 0 0 Challenge 68 66 97.1 53 51 96.2 66 97.1 59 2 0 0 Combined 308 303 98.4 283 278 98.2 302 98.1 119 6 0 0 P. aeruginosa Clinical 120 119 99.2 113 112 99.1 112 93.3 31 8 0 0 Challenge 20 18 90.0 7 5 71.4 20 100 17 0 0 0 Combined 140 137 97.9 120 117 97.5 132 94.3 48 8 0 0 All Organisms 448 440 98.2 403 395 98.0 434 96.9 167 14 0 0 EA – Essential Agreement min – minor errors CA – Category Agreement maj – major errors EVAL – Evaluable isolates vmj – very major errors R – Resistant isolates Essential Agreement (EA) is when the Liofilchem MIC Test Strip (MST) results agree exactly or within one doubling dilution of the reference broth microdilution results. Category Agreement (CA) is when the Liofilchem MIC Test Strip (MST) result interpretation agrees exactly with the reference broth microdilution result interpretation. The overall performance of all Enterobacteriaceae isolates is acceptable with 98.4% EA and 98.1% CA. There were six minor discrepancies and no major or very major errors. 8 The overall performance of P. aeruginosa is acceptable with 97.9% EA and 94.3% CA. There were eight minor errors and no major or very major errors. The overall performance of all organisms combined is acceptable with 98.2% EA and 96.9% CA. Resistance Mechanism: Molecular characterization was not evaluated for all organisms as this information was not available of the time of testing. This was addressed by adding the following footnote in the labeling: “Characterization of Topoisomerase IV and DNA gyrase quinolone-resistance determining regions (QRDRs) and altered efflux resistance mechanisms was not available for organisms at the time of comparative testing, and therefore the performance of Liofilchem MIC Test Strip Delafloxacin MTS for non-fastidious Gram negative bacilli with these resistance mechanisms is unknown for the following: Enterobacteriaceae, P. aeruginosa” b. Matrix comparison: Not Applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable 4. Clinical cut-off: Not Applicable 9 5. Expected values/Reference range: The FDA susceptibility interpretive criteria for Delafloxacin are as listed in Table 5. Table 5: FDA Interpretive Criteria for Delafloxacin (µg/mL) Organisms S I R Enterobacteriaceae ≤0.25 0.5 ≥1 P. aeruginosa ≤0.5 1 ≥2 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK180886_s2000_e4000

K180886.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

CFU/mL. Colony counts was also determined from one replicate of each reproducibility isolate on each of the three days of testing and from a minimum of 10% of the clinical strains tested. d. Detection limit: Not Applicable e. Analytical specificity: Not Applicable f. Assay cut-off: Not Applicable 2. Comparison studies: a. Method comparison with predicate device: Results obtained with Liofilchem MIC Test Strip (MTS) with Delafloxacin were compared to results obtained from frozen reference MIC panels. Reference panels were prepared and interpreted as outlined in the recommendations in CLSI document M7-A10. Isolated colonies from an overnight blood agar plate were suspended in saline to achieve a 0.5 McFarland standard turbidity (approximately 108 CFU/mL). Testing conditions consisted of incubation of the inoculated Mueller Hinton agar plates in and 7 inverted position at 35°C ±2 for 16-20 hours. At the end of incubation, the MIC value where the edge of the inhibition ellipse intersects the strip was compared to the reference method. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Delafloxacin was 100% Clinical: Clinical testing was performed at three US sites. A total of 360 clinical isolates were tested which included 240 Enterobacteriaceae isolates (15 K. aerogenes, 45 E. cloacae, 90 E. coli, 15 K. oxytoca, 60 K. pneumoniae, 15 P. mirabilis) and 120 P. aeruginosa. 65.6% of the clinical isolates were collected within 6 months of isolation. Challenge: Challenge testing was performed at one internal site. A total of 88 challenge isolates were tested which included 68 Enterobacteriaceae isolates (5 K. aerogenes, 14 E. cloacae, 21 E. coli, 5 K. oxytoca, 20 K. pneumoniae, 3 P. mirabilis) and 20 P. aeruginosa isolates. The total of 448 clinical and challenge isolates is summarized in Table 3 below. Table 3: Overall Performance of Clinical and Challenge Isolates (Combined) Delafloxacin EA Tot EA N EA % Eval. EA Tot Eval. EA N Eval. EA% CA N CA % #R min maj vmj Enterobacteriaceae (all) Clinical 240 237 98.8 230 227 98.7 236 98.3 60 4 0 0 Challenge 68 66 97.1 53 51 96.2 66 97.1 59 2 0 0 Combined 308 303 98.4 283 278 98.2 302 98.1 119 6 0 0 P. aeruginosa Clinical 120 119 99.2 113 112 99.1 112 93.3 31 8 0 0 Challenge 20 18 90.0 7 5 71.4 20 100 17 0 0 0 Combined 140 137 97.9 120 117 97.5 132 94.3 48 8 0 0 All Organisms 448 440 98.2 403 395 98.0 434 96.9 167 14 0 0 EA – Essential Agreement min – minor errors CA – Category Agreement maj – major errors EVAL – Evaluable isolates vmj – very major errors R – Resistant isolates Essential Agreement (EA) is when the Liofilchem MIC Test Strip (MST) results agree exactly or within one doubling dilution of the reference broth microdilution results. Category Agreement (CA) is when the Liofilchem MIC Test Strip (MST) result interpretation agrees exactly with the reference broth microdilution result interpretation. The overall performance of all Enterobacteriaceae isolates is acceptable with 98.4% EA and 98.1% CA. There were six minor discrepancies and no major or very major errors. 8 The overall performance of P. aeruginosa is acceptable with 97.9% EA and 94.3% CA. There were eight minor errors and no major or very major errors. The overall performance of all organisms combined is acceptable with 98.2% EA and 96.9% CA. Resistance Mechanism: Molecular characterization was not evaluated for all organisms as this information was not available of the time of testing. This was addressed by adding the following footnote in the labeling: “Characterization of Topoisomerase IV and DNA gyrase quinolone-resistance determining regions (QRDRs) and altered efflux resistance mechanisms was not available for organisms at the time of comparative testing, and therefore the performance of Liofilchem MIC Test Strip Delafloxacin MTS for non-fastidious Gram negative bacilli with these resistance mechanisms is unknown for the following: Enterobacteriaceae, P. aeruginosa” b. Matrix comparison: Not Applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable 4. Clinical cut-off: Not Applicable 9 5. Expected values/Reference range: The FDA susceptibility interpretive criteria for Delafloxacin are as listed in Table 5. Table 5: FDA Interpretive Criteria for Delafloxacin (µg/mL) Organisms S I R Enterobacteriaceae ≤0.25 0.5 ≥1 P. aeruginosa ≤0.5 1 ≥2 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK143075_s0_e2000

K143075.txt

purpose for submission

New Device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143075 B. Purpose for Submission: New Device C. Measurand: Sex Hormone Binding Globulin (SHBG) D. Type of Test: Quantitative immunoassay E. Applicant: Tosoh Bioscience F. Proprietary and Established Names: ST AIA-PACK SHBG ST AIA-PACK SHBG Calibrator Set G. Regulatory Information: Product Code Classification Regulation Section Panel CDZ Class I, reserved 21 CFR 862.1680 Clinical Chemistry (75) JIT Class II 21 CFR 862.1150 Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below 2 2. Indication(s) for use: ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Tosoh AIA-2000 System Analyzer I. Device Description: The ST AIA-PACK SHBG consists of 5 trays of 20 test cups which contain twelve lyophilized magnetic beads coated with anti-SHBG mouse monoclonal antibody and 100 µL of anti-SHBG mouse monoclonal antibody conjugated to bovine alkaline phosphatase with sodium azide as a preservative. ST AIA-PACK Sample Diluting Solution (sold separately) consists of a protein matrix with no detectable concentration of SHBG with sodium azide as a preservative. The ST AIA-PACK SHBG Calibrator Set contains a protein matrix with assigned levels of sex hormone binding globulin (SHBG). The calibrator set contains six levels of calibrators with the following SHBG concentrations: 0, 0.10, 0.30, 1.25, 6.25, and 15.0 nmol/L. The calibrators are supplied at a 1:20 dilution; therefore, the measured concentrations would be equivalent to 0, 2.0, 6.0, 25.0, 125.0, and 300 nmol/L after the analyzer performs an automatic multiplication by a factor of 20. Each serum/plasma donor unit used in the preparation of these products has been tested by an U.S. FDA approved method and found to be non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2, the Hepatitis B surface antigen, and the antibody to Hepatitis C. J. Substantial Equivalence Information: 1. Predicate device name(s): Architect SHBG Reagent Kit Architect SHBG Calibrator Kit 3 2. Predicate 510(k) number(s): k060818 3. Comparison with predicate: SHBG assay Similarities Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Intended Use For the quantitative measurement of sex hormone binding globulin (SHBG) in human serum and plasma for use as an aid in the diagnosis of androgen disorders. Same Antibody Anti-SHBG mouse monoclonal antibody Same SHBG assay Differences Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Reference range Premenopausal women: 18-260 nmol/L Postmenopausal women: 15-185 nmol/L Males (21-49 years old): 10-68 nmol/L Males (≥50 years old): 16-125nmol/L Females: 11.7-137.2 nmol/L Males: 11.2-78.1 nmol/L Test Methodology Fluorescence Immunoassay Chemiluminscent Microparticle Immunoassay (CMIA) Specimen type Serum or sodium heparinized plasma Serum or lithium heparin, sodium heparin, ammonium heparin, potassium EDTA plasma. Measuring Range 0.2 to 250 nmol/L 0.1- 250 nmol/L 4 SHBG Calibrators Similarities and Differences Item Candidate Device ST AIA-PACK SHBG Calibrator Set Predicate Device Architect SHBG Calibrator Kit (k060818) Intended Use Intended for the calibration of the SHBG assay. Same Number of Levels 6 Same Matrix Bovine serum albumin Human serum in buffer Traceability Traceable to the WHO 2nd International Standard for SHBG from the National Institute for Biological Standards and Control (NIBSC) code 08/266. Traceable to the WHO standard Material NIBSC code: 95/560 K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach; Approved Guideline CLSI EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition CLSI EP9-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition L. Test Principle: The ST AIA-PACK SHBG is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK SHBG test cups. SHBG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the test cups. The magnetic beads are washed to remove unbound 5 enzyme-labeled antibody and are then incubated with a fluorogenic substrate, 4- methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the SHBG concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve. The concentration of range of the calibration curve is displayed in 1/20th of the assay range in patient specimens. The concentrations of patient specimens and control material are calculated by multiplying the concentrations obtain on the calibration curve with the dilution factor. The AIA-2000 analyzer will automatically calculate the concentrations of patient samples and controls using the dilution factor and report the results. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision was assessed by assaying three levels of serum and Na-heparin plasma samples. The precision for the ST AIA-PACK SHBG assay was evaluated using three AIA-2000 analyzers and three different lots of reagent for both serum and Na- heparin plasma samples. Total and within run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days (n=80). The precision results for each of the three lots assayed were similar. The study results of one representative lot are provided in the table below: Precision data from one representative lot: Within-Run Between-Run Total Sample n Mean SHBG (nmol/L) SD %CV SD %CV SD %CV Serum 1 80 18.0 0.39 2.1 0.37 2.0 0.53 3.0 Serum 2 80 54.8 1.29 2.3 1.32 2.4 1.8 3.3 Serum 3 80 158.9 4.07 2.6 3.39 2.1 4.93 3.1 Plasma 1 80 16.1 0.40 2.4 0.4 2.5 0.6 3.4 Plasma 2 80 65.2 1.0 1.6 1.0 1.5 1.5 2.3 Plasma 3 80 142.2 3.7 2.6 2.9 2.0 2.0 3.1 All the data were combined to assess the within-run, between-run, between-day, between-lot and total precision. The results are provided in the table below: 6 Combined precision data: Within-Run Between-Run Between-Lot Total Sample n=240 Mean SHBG (nmol/L) SD %CV SD %CV SD %CV SD %CV Serum 1 18.1 0.47 2.6 0.38 2.1 0.77 4.3 0.84 4.6 Serum 2 55.3 1.39 2.5 1.21 2.2 1.54 2.8 2.88 5.2 Serum 3 163.1 4.79 2.9 4.10 2.5 2.77 1.7 9.42 5.8 Plasma 1 16.3 0.43 2 Purpose for submission:

idK143075_s0_e2000

K143075.txt

measurand

Sex Hormone Binding Globulin (SHBG)

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143075 B. Purpose for Submission: New Device C. Measurand: Sex Hormone Binding Globulin (SHBG) D. Type of Test: Quantitative immunoassay E. Applicant: Tosoh Bioscience F. Proprietary and Established Names: ST AIA-PACK SHBG ST AIA-PACK SHBG Calibrator Set G. Regulatory Information: Product Code Classification Regulation Section Panel CDZ Class I, reserved 21 CFR 862.1680 Clinical Chemistry (75) JIT Class II 21 CFR 862.1150 Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below 2 2. Indication(s) for use: ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Tosoh AIA-2000 System Analyzer I. Device Description: The ST AIA-PACK SHBG consists of 5 trays of 20 test cups which contain twelve lyophilized magnetic beads coated with anti-SHBG mouse monoclonal antibody and 100 µL of anti-SHBG mouse monoclonal antibody conjugated to bovine alkaline phosphatase with sodium azide as a preservative. ST AIA-PACK Sample Diluting Solution (sold separately) consists of a protein matrix with no detectable concentration of SHBG with sodium azide as a preservative. The ST AIA-PACK SHBG Calibrator Set contains a protein matrix with assigned levels of sex hormone binding globulin (SHBG). The calibrator set contains six levels of calibrators with the following SHBG concentrations: 0, 0.10, 0.30, 1.25, 6.25, and 15.0 nmol/L. The calibrators are supplied at a 1:20 dilution; therefore, the measured concentrations would be equivalent to 0, 2.0, 6.0, 25.0, 125.0, and 300 nmol/L after the analyzer performs an automatic multiplication by a factor of 20. Each serum/plasma donor unit used in the preparation of these products has been tested by an U.S. FDA approved method and found to be non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2, the Hepatitis B surface antigen, and the antibody to Hepatitis C. J. Substantial Equivalence Information: 1. Predicate device name(s): Architect SHBG Reagent Kit Architect SHBG Calibrator Kit 3 2. Predicate 510(k) number(s): k060818 3. Comparison with predicate: SHBG assay Similarities Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Intended Use For the quantitative measurement of sex hormone binding globulin (SHBG) in human serum and plasma for use as an aid in the diagnosis of androgen disorders. Same Antibody Anti-SHBG mouse monoclonal antibody Same SHBG assay Differences Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Reference range Premenopausal women: 18-260 nmol/L Postmenopausal women: 15-185 nmol/L Males (21-49 years old): 10-68 nmol/L Males (≥50 years old): 16-125nmol/L Females: 11.7-137.2 nmol/L Males: 11.2-78.1 nmol/L Test Methodology Fluorescence Immunoassay Chemiluminscent Microparticle Immunoassay (CMIA) Specimen type Serum or sodium heparinized plasma Serum or lithium heparin, sodium heparin, ammonium heparin, potassium EDTA plasma. Measuring Range 0.2 to 250 nmol/L 0.1- 250 nmol/L 4 SHBG Calibrators Similarities and Differences Item Candidate Device ST AIA-PACK SHBG Calibrator Set Predicate Device Architect SHBG Calibrator Kit (k060818) Intended Use Intended for the calibration of the SHBG assay. Same Number of Levels 6 Same Matrix Bovine serum albumin Human serum in buffer Traceability Traceable to the WHO 2nd International Standard for SHBG from the National Institute for Biological Standards and Control (NIBSC) code 08/266. Traceable to the WHO standard Material NIBSC code: 95/560 K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach; Approved Guideline CLSI EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition CLSI EP9-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition L. Test Principle: The ST AIA-PACK SHBG is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK SHBG test cups. SHBG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the test cups. The magnetic beads are washed to remove unbound 5 enzyme-labeled antibody and are then incubated with a fluorogenic substrate, 4- methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the SHBG concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve. The concentration of range of the calibration curve is displayed in 1/20th of the assay range in patient specimens. The concentrations of patient specimens and control material are calculated by multiplying the concentrations obtain on the calibration curve with the dilution factor. The AIA-2000 analyzer will automatically calculate the concentrations of patient samples and controls using the dilution factor and report the results. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision was assessed by assaying three levels of serum and Na-heparin plasma samples. The precision for the ST AIA-PACK SHBG assay was evaluated using three AIA-2000 analyzers and three different lots of reagent for both serum and Na- heparin plasma samples. Total and within run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days (n=80). The precision results for each of the three lots assayed were similar. The study results of one representative lot are provided in the table below: Precision data from one representative lot: Within-Run Between-Run Total Sample n Mean SHBG (nmol/L) SD %CV SD %CV SD %CV Serum 1 80 18.0 0.39 2.1 0.37 2.0 0.53 3.0 Serum 2 80 54.8 1.29 2.3 1.32 2.4 1.8 3.3 Serum 3 80 158.9 4.07 2.6 3.39 2.1 4.93 3.1 Plasma 1 80 16.1 0.40 2.4 0.4 2.5 0.6 3.4 Plasma 2 80 65.2 1.0 1.6 1.0 1.5 1.5 2.3 Plasma 3 80 142.2 3.7 2.6 2.9 2.0 2.0 3.1 All the data were combined to assess the within-run, between-run, between-day, between-lot and total precision. The results are provided in the table below: 6 Combined precision data: Within-Run Between-Run Between-Lot Total Sample n=240 Mean SHBG (nmol/L) SD %CV SD %CV SD %CV SD %CV Serum 1 18.1 0.47 2.6 0.38 2.1 0.77 4.3 0.84 4.6 Serum 2 55.3 1.39 2.5 1.21 2.2 1.54 2.8 2.88 5.2 Serum 3 163.1 4.79 2.9 4.10 2.5 2.77 1.7 9.42 5.8 Plasma 1 16.3 0.43 2 Measurand:

idK143075_s0_e2000

K143075.txt

type of test

Quantitative immunoassay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143075 B. Purpose for Submission: New Device C. Measurand: Sex Hormone Binding Globulin (SHBG) D. Type of Test: Quantitative immunoassay E. Applicant: Tosoh Bioscience F. Proprietary and Established Names: ST AIA-PACK SHBG ST AIA-PACK SHBG Calibrator Set G. Regulatory Information: Product Code Classification Regulation Section Panel CDZ Class I, reserved 21 CFR 862.1680 Clinical Chemistry (75) JIT Class II 21 CFR 862.1150 Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below 2 2. Indication(s) for use: ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Tosoh AIA-2000 System Analyzer I. Device Description: The ST AIA-PACK SHBG consists of 5 trays of 20 test cups which contain twelve lyophilized magnetic beads coated with anti-SHBG mouse monoclonal antibody and 100 µL of anti-SHBG mouse monoclonal antibody conjugated to bovine alkaline phosphatase with sodium azide as a preservative. ST AIA-PACK Sample Diluting Solution (sold separately) consists of a protein matrix with no detectable concentration of SHBG with sodium azide as a preservative. The ST AIA-PACK SHBG Calibrator Set contains a protein matrix with assigned levels of sex hormone binding globulin (SHBG). The calibrator set contains six levels of calibrators with the following SHBG concentrations: 0, 0.10, 0.30, 1.25, 6.25, and 15.0 nmol/L. The calibrators are supplied at a 1:20 dilution; therefore, the measured concentrations would be equivalent to 0, 2.0, 6.0, 25.0, 125.0, and 300 nmol/L after the analyzer performs an automatic multiplication by a factor of 20. Each serum/plasma donor unit used in the preparation of these products has been tested by an U.S. FDA approved method and found to be non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2, the Hepatitis B surface antigen, and the antibody to Hepatitis C. J. Substantial Equivalence Information: 1. Predicate device name(s): Architect SHBG Reagent Kit Architect SHBG Calibrator Kit 3 2. Predicate 510(k) number(s): k060818 3. Comparison with predicate: SHBG assay Similarities Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Intended Use For the quantitative measurement of sex hormone binding globulin (SHBG) in human serum and plasma for use as an aid in the diagnosis of androgen disorders. Same Antibody Anti-SHBG mouse monoclonal antibody Same SHBG assay Differences Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Reference range Premenopausal women: 18-260 nmol/L Postmenopausal women: 15-185 nmol/L Males (21-49 years old): 10-68 nmol/L Males (≥50 years old): 16-125nmol/L Females: 11.7-137.2 nmol/L Males: 11.2-78.1 nmol/L Test Methodology Fluorescence Immunoassay Chemiluminscent Microparticle Immunoassay (CMIA) Specimen type Serum or sodium heparinized plasma Serum or lithium heparin, sodium heparin, ammonium heparin, potassium EDTA plasma. Measuring Range 0.2 to 250 nmol/L 0.1- 250 nmol/L 4 SHBG Calibrators Similarities and Differences Item Candidate Device ST AIA-PACK SHBG Calibrator Set Predicate Device Architect SHBG Calibrator Kit (k060818) Intended Use Intended for the calibration of the SHBG assay. Same Number of Levels 6 Same Matrix Bovine serum albumin Human serum in buffer Traceability Traceable to the WHO 2nd International Standard for SHBG from the National Institute for Biological Standards and Control (NIBSC) code 08/266. Traceable to the WHO standard Material NIBSC code: 95/560 K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach; Approved Guideline CLSI EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition CLSI EP9-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition L. Test Principle: The ST AIA-PACK SHBG is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK SHBG test cups. SHBG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the test cups. The magnetic beads are washed to remove unbound 5 enzyme-labeled antibody and are then incubated with a fluorogenic substrate, 4- methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the SHBG concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve. The concentration of range of the calibration curve is displayed in 1/20th of the assay range in patient specimens. The concentrations of patient specimens and control material are calculated by multiplying the concentrations obtain on the calibration curve with the dilution factor. The AIA-2000 analyzer will automatically calculate the concentrations of patient samples and controls using the dilution factor and report the results. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision was assessed by assaying three levels of serum and Na-heparin plasma samples. The precision for the ST AIA-PACK SHBG assay was evaluated using three AIA-2000 analyzers and three different lots of reagent for both serum and Na- heparin plasma samples. Total and within run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days (n=80). The precision results for each of the three lots assayed were similar. The study results of one representative lot are provided in the table below: Precision data from one representative lot: Within-Run Between-Run Total Sample n Mean SHBG (nmol/L) SD %CV SD %CV SD %CV Serum 1 80 18.0 0.39 2.1 0.37 2.0 0.53 3.0 Serum 2 80 54.8 1.29 2.3 1.32 2.4 1.8 3.3 Serum 3 80 158.9 4.07 2.6 3.39 2.1 4.93 3.1 Plasma 1 80 16.1 0.40 2.4 0.4 2.5 0.6 3.4 Plasma 2 80 65.2 1.0 1.6 1.0 1.5 1.5 2.3 Plasma 3 80 142.2 3.7 2.6 2.9 2.0 2.0 3.1 All the data were combined to assess the within-run, between-run, between-day, between-lot and total precision. The results are provided in the table below: 6 Combined precision data: Within-Run Between-Run Between-Lot Total Sample n=240 Mean SHBG (nmol/L) SD %CV SD %CV SD %CV SD %CV Serum 1 18.1 0.47 2.6 0.38 2.1 0.77 4.3 0.84 4.6 Serum 2 55.3 1.39 2.5 1.21 2.2 1.54 2.8 2.88 5.2 Serum 3 163.1 4.79 2.9 4.10 2.5 2.77 1.7 9.42 5.8 Plasma 1 16.3 0.43 2 Type of test:

idK143075_s0_e2000

K143075.txt

intended use

See Indication(s) for use below

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143075 B. Purpose for Submission: New Device C. Measurand: Sex Hormone Binding Globulin (SHBG) D. Type of Test: Quantitative immunoassay E. Applicant: Tosoh Bioscience F. Proprietary and Established Names: ST AIA-PACK SHBG ST AIA-PACK SHBG Calibrator Set G. Regulatory Information: Product Code Classification Regulation Section Panel CDZ Class I, reserved 21 CFR 862.1680 Clinical Chemistry (75) JIT Class II 21 CFR 862.1150 Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below 2 2. Indication(s) for use: ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Tosoh AIA-2000 System Analyzer I. Device Description: The ST AIA-PACK SHBG consists of 5 trays of 20 test cups which contain twelve lyophilized magnetic beads coated with anti-SHBG mouse monoclonal antibody and 100 µL of anti-SHBG mouse monoclonal antibody conjugated to bovine alkaline phosphatase with sodium azide as a preservative. ST AIA-PACK Sample Diluting Solution (sold separately) consists of a protein matrix with no detectable concentration of SHBG with sodium azide as a preservative. The ST AIA-PACK SHBG Calibrator Set contains a protein matrix with assigned levels of sex hormone binding globulin (SHBG). The calibrator set contains six levels of calibrators with the following SHBG concentrations: 0, 0.10, 0.30, 1.25, 6.25, and 15.0 nmol/L. The calibrators are supplied at a 1:20 dilution; therefore, the measured concentrations would be equivalent to 0, 2.0, 6.0, 25.0, 125.0, and 300 nmol/L after the analyzer performs an automatic multiplication by a factor of 20. Each serum/plasma donor unit used in the preparation of these products has been tested by an U.S. FDA approved method and found to be non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2, the Hepatitis B surface antigen, and the antibody to Hepatitis C. J. Substantial Equivalence Information: 1. Predicate device name(s): Architect SHBG Reagent Kit Architect SHBG Calibrator Kit 3 2. Predicate 510(k) number(s): k060818 3. Comparison with predicate: SHBG assay Similarities Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Intended Use For the quantitative measurement of sex hormone binding globulin (SHBG) in human serum and plasma for use as an aid in the diagnosis of androgen disorders. Same Antibody Anti-SHBG mouse monoclonal antibody Same SHBG assay Differences Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Reference range Premenopausal women: 18-260 nmol/L Postmenopausal women: 15-185 nmol/L Males (21-49 years old): 10-68 nmol/L Males (≥50 years old): 16-125nmol/L Females: 11.7-137.2 nmol/L Males: 11.2-78.1 nmol/L Test Methodology Fluorescence Immunoassay Chemiluminscent Microparticle Immunoassay (CMIA) Specimen type Serum or sodium heparinized plasma Serum or lithium heparin, sodium heparin, ammonium heparin, potassium EDTA plasma. Measuring Range 0.2 to 250 nmol/L 0.1- 250 nmol/L 4 SHBG Calibrators Similarities and Differences Item Candidate Device ST AIA-PACK SHBG Calibrator Set Predicate Device Architect SHBG Calibrator Kit (k060818) Intended Use Intended for the calibration of the SHBG assay. Same Number of Levels 6 Same Matrix Bovine serum albumin Human serum in buffer Traceability Traceable to the WHO 2nd International Standard for SHBG from the National Institute for Biological Standards and Control (NIBSC) code 08/266. Traceable to the WHO standard Material NIBSC code: 95/560 K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach; Approved Guideline CLSI EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition CLSI EP9-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition L. Test Principle: The ST AIA-PACK SHBG is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK SHBG test cups. SHBG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the test cups. The magnetic beads are washed to remove unbound 5 enzyme-labeled antibody and are then incubated with a fluorogenic substrate, 4- methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the SHBG concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve. The concentration of range of the calibration curve is displayed in 1/20th of the assay range in patient specimens. The concentrations of patient specimens and control material are calculated by multiplying the concentrations obtain on the calibration curve with the dilution factor. The AIA-2000 analyzer will automatically calculate the concentrations of patient samples and controls using the dilution factor and report the results. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision was assessed by assaying three levels of serum and Na-heparin plasma samples. The precision for the ST AIA-PACK SHBG assay was evaluated using three AIA-2000 analyzers and three different lots of reagent for both serum and Na- heparin plasma samples. Total and within run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days (n=80). The precision results for each of the three lots assayed were similar. The study results of one representative lot are provided in the table below: Precision data from one representative lot: Within-Run Between-Run Total Sample n Mean SHBG (nmol/L) SD %CV SD %CV SD %CV Serum 1 80 18.0 0.39 2.1 0.37 2.0 0.53 3.0 Serum 2 80 54.8 1.29 2.3 1.32 2.4 1.8 3.3 Serum 3 80 158.9 4.07 2.6 3.39 2.1 4.93 3.1 Plasma 1 80 16.1 0.40 2.4 0.4 2.5 0.6 3.4 Plasma 2 80 65.2 1.0 1.6 1.0 1.5 1.5 2.3 Plasma 3 80 142.2 3.7 2.6 2.9 2.0 2.0 3.1 All the data were combined to assess the within-run, between-run, between-day, between-lot and total precision. The results are provided in the table below: 6 Combined precision data: Within-Run Between-Run Between-Lot Total Sample n=240 Mean SHBG (nmol/L) SD %CV SD %CV SD %CV SD %CV Serum 1 18.1 0.47 2.6 0.38 2.1 0.77 4.3 0.84 4.6 Serum 2 55.3 1.39 2.5 1.21 2.2 1.54 2.8 2.88 5.2 Serum 3 163.1 4.79 2.9 4.10 2.5 2.77 1.7 9.42 5.8 Plasma 1 16.3 0.43 2 Intended use:

idK143075_s0_e2000

K143075.txt

applicant

Tosoh Bioscience

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k143075 B. Purpose for Submission: New Device C. Measurand: Sex Hormone Binding Globulin (SHBG) D. Type of Test: Quantitative immunoassay E. Applicant: Tosoh Bioscience F. Proprietary and Established Names: ST AIA-PACK SHBG ST AIA-PACK SHBG Calibrator Set G. Regulatory Information: Product Code Classification Regulation Section Panel CDZ Class I, reserved 21 CFR 862.1680 Clinical Chemistry (75) JIT Class II 21 CFR 862.1150 Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below 2 2. Indication(s) for use: ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Tosoh AIA-2000 System Analyzer I. Device Description: The ST AIA-PACK SHBG consists of 5 trays of 20 test cups which contain twelve lyophilized magnetic beads coated with anti-SHBG mouse monoclonal antibody and 100 µL of anti-SHBG mouse monoclonal antibody conjugated to bovine alkaline phosphatase with sodium azide as a preservative. ST AIA-PACK Sample Diluting Solution (sold separately) consists of a protein matrix with no detectable concentration of SHBG with sodium azide as a preservative. The ST AIA-PACK SHBG Calibrator Set contains a protein matrix with assigned levels of sex hormone binding globulin (SHBG). The calibrator set contains six levels of calibrators with the following SHBG concentrations: 0, 0.10, 0.30, 1.25, 6.25, and 15.0 nmol/L. The calibrators are supplied at a 1:20 dilution; therefore, the measured concentrations would be equivalent to 0, 2.0, 6.0, 25.0, 125.0, and 300 nmol/L after the analyzer performs an automatic multiplication by a factor of 20. Each serum/plasma donor unit used in the preparation of these products has been tested by an U.S. FDA approved method and found to be non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2, the Hepatitis B surface antigen, and the antibody to Hepatitis C. J. Substantial Equivalence Information: 1. Predicate device name(s): Architect SHBG Reagent Kit Architect SHBG Calibrator Kit 3 2. Predicate 510(k) number(s): k060818 3. Comparison with predicate: SHBG assay Similarities Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Intended Use For the quantitative measurement of sex hormone binding globulin (SHBG) in human serum and plasma for use as an aid in the diagnosis of androgen disorders. Same Antibody Anti-SHBG mouse monoclonal antibody Same SHBG assay Differences Item Candidate Device ST AIA-PACK SHBG Predicate Device Architect SHBG Reagent Kit (k060818) Reference range Premenopausal women: 18-260 nmol/L Postmenopausal women: 15-185 nmol/L Males (21-49 years old): 10-68 nmol/L Males (≥50 years old): 16-125nmol/L Females: 11.7-137.2 nmol/L Males: 11.2-78.1 nmol/L Test Methodology Fluorescence Immunoassay Chemiluminscent Microparticle Immunoassay (CMIA) Specimen type Serum or sodium heparinized plasma Serum or lithium heparin, sodium heparin, ammonium heparin, potassium EDTA plasma. Measuring Range 0.2 to 250 nmol/L 0.1- 250 nmol/L 4 SHBG Calibrators Similarities and Differences Item Candidate Device ST AIA-PACK SHBG Calibrator Set Predicate Device Architect SHBG Calibrator Kit (k060818) Intended Use Intended for the calibration of the SHBG assay. Same Number of Levels 6 Same Matrix Bovine serum albumin Human serum in buffer Traceability Traceable to the WHO 2nd International Standard for SHBG from the National Institute for Biological Standards and Control (NIBSC) code 08/266. Traceable to the WHO standard Material NIBSC code: 95/560 K. Standard/Guidance Document Referenced (if applicable): CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach; Approved Guideline CLSI EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition CLSI EP9-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition L. Test Principle: The ST AIA-PACK SHBG is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK SHBG test cups. SHBG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the test cups. The magnetic beads are washed to remove unbound 5 enzyme-labeled antibody and are then incubated with a fluorogenic substrate, 4- methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the SHBG concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve. The concentration of range of the calibration curve is displayed in 1/20th of the assay range in patient specimens. The concentrations of patient specimens and control material are calculated by multiplying the concentrations obtain on the calibration curve with the dilution factor. The AIA-2000 analyzer will automatically calculate the concentrations of patient samples and controls using the dilution factor and report the results. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision was assessed by assaying three levels of serum and Na-heparin plasma samples. The precision for the ST AIA-PACK SHBG assay was evaluated using three AIA-2000 analyzers and three different lots of reagent for both serum and Na- heparin plasma samples. Total and within run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days (n=80). The precision results for each of the three lots assayed were similar. The study results of one representative lot are provided in the table below: Precision data from one representative lot: Within-Run Between-Run Total Sample n Mean SHBG (nmol/L) SD %CV SD %CV SD %CV Serum 1 80 18.0 0.39 2.1 0.37 2.0 0.53 3.0 Serum 2 80 54.8 1.29 2.3 1.32 2.4 1.8 3.3 Serum 3 80 158.9 4.07 2.6 3.39 2.1 4.93 3.1 Plasma 1 80 16.1 0.40 2.4 0.4 2.5 0.6 3.4 Plasma 2 80 65.2 1.0 1.6 1.0 1.5 1.5 2.3 Plasma 3 80 142.2 3.7 2.6 2.9 2.0 2.0 3.1 All the data were combined to assess the within-run, between-run, between-day, between-lot and total precision. The results are provided in the table below: 6 Combined precision data: Within-Run Between-Run Between-Lot Total Sample n=240 Mean SHBG (nmol/L) SD %CV SD %CV SD %CV SD %CV Serum 1 18.1 0.47 2.6 0.38 2.1 0.77 4.3 0.84 4.6 Serum 2 55.3 1.39 2.5 1.21 2.2 1.54 2.8 2.88 5.2 Serum 3 163.1 4.79 2.9 4.10 2.5 2.77 1.7 9.42 5.8 Plasma 1 16.3 0.43 2 Applicant:

idK143075_s4000_e6000

K143075.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

SHBG assay on the AIA-2000 analyzer. A total of 116 serum and Na heparin plasma samples were assayed at two sites using two analyzers and one lot of reagent. The serum results ranged from 0.2 to 219 nmol/L. Five samples each of serum and Na-heparin plasma were diluted in order to cover the entire claimed measuring range. The results of the matrix comparison study are summarized in the table below: Serum vs Na-heparin plasma n Slope 95% CI Intercept 95% CI R 116 0.977 0.964 to 0.991 0.269 -0.629 to 1.168 0.997 11 The study data support the package insert claim that human serum and Na-Heparin plasma are acceptable sample types for use with ST AIA-PACK SHBG assay. The sponsor indicates in the package insert labeling that EDTA plasma or citrated plasma should not be used. 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The reference range study was conducted with reference to the CLSI C28-A3 guideline. A total of 122 pre-menopausal (21 years and older) and 122 post-menopausal female serum specimens were assayed in singleton utilizing the Tosoh ST AIA-PACK SHBG assay. In addition, all samples were assayed in singleton utilizing the Tosoh ST AIA- PACK Testosterone. A total of 121 males between the ages of 21 and 49 years of age and 123 males over the age of 50 years of age were assayed in singleton utilizing the Tosoh ST AIA-PACK SHBG assay. In addition, all samples were assayed in singleton utilizing the Tosoh ST AIAPACK Testosterone. Testing was done at one site utilizing AIA-2000 analyzer and three lot numbers of reagents. The results from both assays were used to calculate the Free Androgen Index (%FAI). Reference Range for SHBG Subject Group N SHBG range ( nmol/L) Premenopausal women 122 18-260 Postmenopausal women 122 15-185 Men 21-49 years old 121 10-68 Men ≥50 years old 123 16-125 12 Reference Range for Free Androgen Index Subject Group N Free Androgen Index 2.5 to 97.5th percentile Premenopausal women 122 0.2-9.7% Postmenopausal women 122 0.1-7.1% Men 21-49 years old 121 14.7-130.4% Men ≥50 years old 123 1.0-72.4% The formula for calculating the Free Androgen Index is: FAI (%) = testosterone value (nmol/L) x100 SHBG value (nmol/L) N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK143075_s4000_e6000

K143075.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

PACK SHBG assay on the AIA-2000 analyzer. A total of 116 serum and Na heparin plasma samples were assayed at two sites using two analyzers and one lot of reagent. The serum results ranged from 0.2 to 219 nmol/L. Five samples each of serum and Na-heparin plasma were diluted in order to cover the entire claimed measuring range. The results of the matrix comparison study are summarized in the table below: Serum vs Na-heparin plasma n Slope 95% CI Intercept 95% CI R 116 0.977 0.964 to 0.991 0.269 -0.629 to 1.168 0.997 11 The study data support the package insert claim that human serum and Na-Heparin plasma are acceptable sample types for use with ST AIA-PACK SHBG assay. The sponsor indicates in the package insert labeling that EDTA plasma or citrated plasma should not be used. 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The reference range study was conducted with reference to the CLSI C28-A3 guideline. A total of 122 pre-menopausal (21 years and older) and 122 post-menopausal female serum specimens were assayed in singleton utilizing the Tosoh ST AIA-PACK SHBG assay. In addition, all samples were assayed in singleton utilizing the Tosoh ST AIA- PACK Testosterone. A total of 121 males between the ages of 21 and 49 years of age and 123 males over the age of 50 years of age were assayed in singleton utilizing the Tosoh ST AIA-PACK SHBG assay. In addition, all samples were assayed in singleton utilizing the Tosoh ST AIAPACK Testosterone. Testing was done at one site utilizing AIA-2000 analyzer and three lot numbers of reagents. The results from both assays were used to calculate the Free Androgen Index (%FAI). Reference Range for SHBG Subject Group N SHBG range ( nmol/L) Premenopausal women 122 18-260 Postmenopausal women 122 15-185 Men 21-49 years old 121 10-68 Men ≥50 years old 123 16-125 12 Reference Range for Free Androgen Index Subject Group N Free Androgen Index 2.5 to 97.5th percentile Premenopausal women 122 0.2-9.7% Postmenopausal women 122 0.1-7.1% Men 21-49 years old 121 14.7-130.4% Men ≥50 years old 123 1.0-72.4% The formula for calculating the Free Androgen Index is: FAI (%) = testosterone value (nmol/L) x100 SHBG value (nmol/L) N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK173505_s0_e2000

K173505.txt

purpose for submission

New Device

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Purpose for submission:

idK173505_s0_e2000

K173505.txt

measurand

Capillary whole blood glucose from the fingertip

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Measurand:

idK173505_s0_e2000

K173505.txt

type of test

Quantitative amperometric assay (Glucose Dehydrogenase FAD)

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Type of test:

idK173505_s0_e2000

K173505.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Classification:

idK173505_s0_e2000

K173505.txt

product code

NBW, System Test, Blood Glucose, Over the Counter

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Product code:

idK173505_s0_e2000

K173505.txt

panel

Clinical Chemistry (75)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Panel:

idK173505_s0_e2000

K173505.txt

intended use

See indication(s) for use below

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Intended use:

idK173505_s0_e2000

K173505.txt

predicate device name

FORA GD43 Blood Glucose Monitoring System

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Predicate device name:

idK173505_s0_e2000

K173505.txt

applicant

ForaCare Inc.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Applicant:

idK173505_s0_e2000

K173505.txt

proprietary and established names

FORA GTel Blood Glucose Monitoring System

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Proprietary and established names:

idK173505_s0_e2000

K173505.txt

regulation section

21 CFR 862.1345, Glucose test system

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K173505 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative amperometric assay (Glucose Dehydrogenase FAD) E. Applicant: ForaCare Inc. F. Proprietary and Established Names: FORA GTel Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System Test, Blood Glucose, Over the Counter 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: FORA GTel Blood Glucose Monitoring System The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared. 3. Special conditions for use statement(s): · For in vitro diagnostic use (for use outside of the body only). This system should not be used for the diagnosis of, or screening for diabetes. · For single-patient use only. · · This system is not for use on patients with abnormally low blood pressure. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis. · This system should not be used on neonates or critically ill patients. · This system should not be used on patients with impaired peripheral circulation, severe dehydration as a result of diabetic ketoacidosis or severe hyperglycemia, hyperosmolar non-ketotic coma or shock. · Altitudes above 10,742 feet may cause inaccurate results. · This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens. 4. Special instrument requirements: FORA GTel Blood Glucose Meter 3 I. Device Description: The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Meter, Owner’s Manual, Protective Wallet, Quick Start User Guide, Daily Log Book, Warranty Card and 1 x Li-ion rechargeable batteries. The FORA GTel Test Strips were previously cleared under k143467 as the FORA GD34 Test Strips and are for use with the FORA GTel Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip. The FORA GTel Test Strips need to be purchased separately. The control solutions to be used with the FORA GTel System are the FORA Control Solutions, Level 1, Level 2, and Level 3 and need to be purchased separately. The FORA GTel Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. J. Substantial Equivalence Information: 1. Predicate device name(s): FORA GD43 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k143467 3. Comparison with predicate: Similarities Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Intended Use Intended for the quantitative measurement of glucose as an aid in monitoring the effectiveness of a diabetes control program. Same Methodology Glucose Dehydrogenase Same Patient-Use Single-patient use Same Intended Use Population Over-the-counter Same Sample Type Capillary whole blood samples drawn from fingertips Same Measurement range 20-600 mg/dL Same 4 Differences Characteristic Candidate Device FORA GTel Blood Glucose Monitoring System Predicate Device FORA GD43 Blood Glucose Monitoring System (k143467) Alternative Sites No Yes, forearm, upper arm, or palm Talking function Yes No Data transmission 3G RS-232 4 Poles K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI EP06-A – Evaluation of Linearity of Quantitative Measurement Methods: A Statistical Approach; Approved Guideline (2003) CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005) IEC/EN 61010-1, Safety requirements for electrical equipment measurement, control, and laboratory use – Part 1: General requirements, Ed 3.0 (2010) IEC 62304, Medical Device Software -Software Life Cycle Processes, Ed 1.1 (2015) L. Test Principle: The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within-run (Repeatability) Within-run precision studies were performed using venous whole blood samples of 5 glucose levels (30-50, 51-110, 111-150, 151-250, 251-400 mg/dL). Samples were 5 tested ten times with each of three lots of test strips with 10 meters for a total of 300 tests per glucose concentration and a grand total of 1500 tests. Results are summarized below: Glucose Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 48.1 1.3 2.7 2 47.9 1.3 2.8 3 48.2 1.3 2.7 51-110 1 101.3 1.7 1.7 2 104.8 1.9 1.8 3 102.0 1.9 1.8 111-150 1 147.2 2.6 1.8 2 151.5 2.0 1.3 3 148.2 2.4 1.6 151-250 1 247.7 3.9 1.6 2 250.5 4.0 1.6 3 244.8 4.3 1.8 251-400 1 398.4 6.5 1.6 2 399.2 6.4 1.6 3 389.6 6.4 1.7 Intermediate Precision Intermediate (between run) precision was evaluated using five levels of glucose control solutions, 3 test strip lots, and 10 meters. Each control solution level was measured once a day for 10 days with each meter and test strip lot, for a total of 100 replicates per control solution level per test strip lot for a total of 300 replicate for each glucose control level. Results are summarized below: Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 30-50 1 49.8 2.02 4.1 2 49.0 2.09 4.3 3 48.8 1.98 4.1 51-110 1 96.0 2.28 2.4 2 95.8 1.94 2.0 3 96.0 1.80 1.9 111-150 1 135.8 2.07 1.5 2 135.2 2.14 1.6 3 134.8 2.32 1.7 151-250 1 225.8 2.77 1.2 2 225.2 2.74 1.2 3 224.6 2.39 1.1 251-400 1 315.4 3.70 1.2 6 Control Solution Level (mg/dL) Lot Mean (mg/dL) SD (mg/dL) CV (%) 2 314.3 3.84 1.2 3 316.5 4.24 1.3 b. Linearity/assay reportable range: Linearity testing was performed using venous whole blood samples spiked to 11 target analyte levels (10, 26, 65, 99, 148, 160, 249, 354, 439, 552, and 621 mg/dL). Each sample was measured in replicates of 15 with 3 test strip lots and 5 meters and the values compared to a laboratory Regulation section:

idK173505_s4000_e6000

K173505.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

, 45, 50, 55, 60, 65 and 70%). Each sample was measured on ten meters for each of three test strip lots and in replicates of four for each of the three test strips with an established a laboratory-based comparator method (YSI 2300). Results of samples at each hematocrit level were compared to samples measured with an established a laboratory-based comparator method (YSI 2300) and support the claimed hematocrit range of 20-60%. 4. Test System Operating Conditions Four FORA GTel meters were used to test venous whole blood samples with three lots of blood glucose test strips. Five test conditions were used in this study: 6 °C/ 10% RH, 6 °C/ 90% RH, 25 °C/ 60% RH, 47 °C/ 10% RH, 47 °C/ 90% RH. The protocol and acceptance criteria for this test were found to be acceptable. The results supported the sponsor’s claimed operating conditions of 46.4 °F-113 °F (8 °C– 45 °C ) and a relative humidity range of 10% to 90%. 12 5. Readability Assessment The readability of the labeling (user manual and test strip insert) using Flesch-Kincaid’s analysis were found to be written not higher than 8th grade level. 6. EMC Testing The sponsor provided documentation certifying that acceptable electromagnetic testing (EMC) has been performed and the System was found to be compliant. 7. Infection Control and Robustness Studies The FORA GTel is intended for a single-patient only. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, MicroKill+ Disinfectant Wipes (EPA registration #598940-10-37549). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleaning and disinfection cycles designed to simulate 5 years of single-patient use. The subject device labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK173505_s4000_e6000

K173505.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

, 40, 45, 50, 55, 60, 65 and 70%). Each sample was measured on ten meters for each of three test strip lots and in replicates of four for each of the three test strips with an established a laboratory-based comparator method (YSI 2300). Results of samples at each hematocrit level were compared to samples measured with an established a laboratory-based comparator method (YSI 2300) and support the claimed hematocrit range of 20-60%. 4. Test System Operating Conditions Four FORA GTel meters were used to test venous whole blood samples with three lots of blood glucose test strips. Five test conditions were used in this study: 6 °C/ 10% RH, 6 °C/ 90% RH, 25 °C/ 60% RH, 47 °C/ 10% RH, 47 °C/ 90% RH. The protocol and acceptance criteria for this test were found to be acceptable. The results supported the sponsor’s claimed operating conditions of 46.4 °F-113 °F (8 °C– 45 °C ) and a relative humidity range of 10% to 90%. 12 5. Readability Assessment The readability of the labeling (user manual and test strip insert) using Flesch-Kincaid’s analysis were found to be written not higher than 8th grade level. 6. EMC Testing The sponsor provided documentation certifying that acceptable electromagnetic testing (EMC) has been performed and the System was found to be compliant. 7. Infection Control and Robustness Studies The FORA GTel is intended for a single-patient only. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, MicroKill+ Disinfectant Wipes (EPA registration #598940-10-37549). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleaning and disinfection cycles designed to simulate 5 years of single-patient use. The subject device labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK162840_s0_e2000

K162840.txt

purpose for submission

New Device

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162840 B. Purpose for Submission: New Device C. Measurand: Total 25-hydroxyvitamin D (25-OH vitamin D) D. Type of Test: Quantitative electrochemiluminescence immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Vitamin D total II Vitamin D total II CalSet PreciControl Vitamin D total II Vitamin D CalCheck G. Regulatory Information: 1. Regulation section: 1 21 CFR 862.1825, Vitamin D Test System 21 CFR 862.1150, Calibrator 21 CFR 862.1660, Quality Control Material (assayed and unassayed) 2. Classification: 2 Class II Class II Class I, reserved 3. Product code: MRG – Vitamin D Test System JIT – Calibrator, secondary JJX – Quality Control Material 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II PreciControl Vitamin D total II is used for quality control of Elecsys Vitamin D total II assay on cobas e 411 immunoassay analyzer. CalCheck Vitamin D total II 3 This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Roche Cobas e 411 analyzer I. Device Description: 1. The Elecsys Vitamin D total II reagent working solutions include: · PT1 Pretreatment reagent 1 (white cap), 1 bottle, 4 mL: Dithiothreitol 1 g/L, pH 5.5. · PT2 Pretreatment reagent 2 (gray cap), 1 bottle, 4 mL: Sodium hydroxide 28 g/L. · M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. · R1 Vitamin D binding protein‑Ru/(bpy) (gray cap), 1 bottle, 6.5 mL: Ruthenium labeled vitamin D binding protein 100 μg/L; bis‑tris propane buffer 100 mmol/L; albumin (human) 40 g/L; pH 6.4; preservative. · R2 25‑hydroxyvitamin D~biotin (black cap), 1 bottle, 6.5 mL: Biotinylated 25‑hydroxyvitamin D 140 μg/L; bis‑tris propane buffer 100 mmol/L; pH 8.6; preservative. 2. Calibrator: CalSet Vitamin D total II is a two concentration level set of lyophilized human serum . The CalSet includes Cal 1 (approximately 2 ng/mL 25-hydroxyvitamin D3 ) and Cal 2 (approximately 45 ng/mL 25-hydroxyvitamin D3). 3. Control: PreciControl Vitamin D total II materials are lyophilized human sera in two concentration ranges. Controls 1 and 2 (CTL 1 & CTL 2) are available in 1.0 mL bottles with two defined concentrations of total 25-hydroxy vitamin D The target concentrations are approximately 13 ng/mL and 30 ng/mL. 4. Calibration Verification Materials: Each set of CalCheck Vitamin D total II contains 5 lyophilized serum levels (1.0 mL). - Check 1: Approximate target range of ≤ 2 ng/mL - Check 2: Approximate target range of 17.5 – 22.4 ng/mL - Check 3: Approximate target range of 46.5 – 54.4 ng/mL - Check 4: Approximate target range of 75.5 – 84.4 ng/mL - Check 5: Approximate target range of 94.5 – > 100 ng/mL The labeling for above materials that contain human blood or serum matrices include the following statement: All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 Elecsys Vitamin D Assay 2. Predicate 510(k) number(s): k113546 3. Comparison with predicate: Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 Intended Use This assay is intended for the quantitative determination of total 25- hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. Same Assay Method Competition principle binding protein Same Detection Method Electrochemiluminescence Same Applications/Test Time 27 minutes Same Calibration Method 2-point calibration based on master curve for specific reagent lot Same LoB, LoD, LoQ 2 ng/mL, 3 ng/mL, 5 ng/mL Same Instrument Platform cobas e 411 Elecsys 2010, MODULAR 5 Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 Sample Type Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Traceability ID-LC-MS/MS traceable to NIST RMP 2972 LC-MS/MS Measuring Range 5 – 100.0 ng/mL 5 – 60.0 ng/mL Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 Intended Use/ CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II Same Analyte 25-hydroxyvitamin D3 25-hydroxyvitamin D Matrix Human serum matrix with added 25-hydroxyvitamin D3 Human serum matrix with added 25-hydroxyvitamin D Target Ranges Cal 1: approximately 2 ng/mL Cal 2: approximately 45 ng/mL Cal 1: approximately 2 ng/mL Cal 2: approximately 37 ng/mL Storage and Stability Reconstituted calibrators: · At 2-8°C – 72 hours · At -20°C – 12 weeks (freeze only once) · On the cobas e 411 analyzer – up to 6 hours Reconstituted calibrators: · At 2-8°C – 120 hours · At -20°C – 90 days (freeze only once) · On the cobas e 411 analyzer – up to 5 hours Calibration Interval Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 3 months (12 weeks) using the same reagent lot · After 7 days (when using Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 1 month (28 days) using the same reagent lot · After 7 days (when using 6 Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits Format Lyophilized Same Similarities and Differences for Control Item Candidate Device PreciControl Vitamin D total II k162840 Predicate device PreciControl Varia k113546 Intended Use PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay Same Analyte 25-hydroxyvitamin D Vitamin B12, Ferritin, Folate β-CTx, Osteocalcin, Parathyroid hormone Purpose for submission:

idK162840_s0_e2000

K162840.txt

measurand

Total 25-hydroxyvitamin D (25-OH vitamin D)

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162840 B. Purpose for Submission: New Device C. Measurand: Total 25-hydroxyvitamin D (25-OH vitamin D) D. Type of Test: Quantitative electrochemiluminescence immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Vitamin D total II Vitamin D total II CalSet PreciControl Vitamin D total II Vitamin D CalCheck G. Regulatory Information: 1. Regulation section: 1 21 CFR 862.1825, Vitamin D Test System 21 CFR 862.1150, Calibrator 21 CFR 862.1660, Quality Control Material (assayed and unassayed) 2. Classification: 2 Class II Class II Class I, reserved 3. Product code: MRG – Vitamin D Test System JIT – Calibrator, secondary JJX – Quality Control Material 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II PreciControl Vitamin D total II is used for quality control of Elecsys Vitamin D total II assay on cobas e 411 immunoassay analyzer. CalCheck Vitamin D total II 3 This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Roche Cobas e 411 analyzer I. Device Description: 1. The Elecsys Vitamin D total II reagent working solutions include: · PT1 Pretreatment reagent 1 (white cap), 1 bottle, 4 mL: Dithiothreitol 1 g/L, pH 5.5. · PT2 Pretreatment reagent 2 (gray cap), 1 bottle, 4 mL: Sodium hydroxide 28 g/L. · M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. · R1 Vitamin D binding protein‑Ru/(bpy) (gray cap), 1 bottle, 6.5 mL: Ruthenium labeled vitamin D binding protein 100 μg/L; bis‑tris propane buffer 100 mmol/L; albumin (human) 40 g/L; pH 6.4; preservative. · R2 25‑hydroxyvitamin D~biotin (black cap), 1 bottle, 6.5 mL: Biotinylated 25‑hydroxyvitamin D 140 μg/L; bis‑tris propane buffer 100 mmol/L; pH 8.6; preservative. 2. Calibrator: CalSet Vitamin D total II is a two concentration level set of lyophilized human serum . The CalSet includes Cal 1 (approximately 2 ng/mL 25-hydroxyvitamin D3 ) and Cal 2 (approximately 45 ng/mL 25-hydroxyvitamin D3). 3. Control: PreciControl Vitamin D total II materials are lyophilized human sera in two concentration ranges. Controls 1 and 2 (CTL 1 & CTL 2) are available in 1.0 mL bottles with two defined concentrations of total 25-hydroxy vitamin D The target concentrations are approximately 13 ng/mL and 30 ng/mL. 4. Calibration Verification Materials: Each set of CalCheck Vitamin D total II contains 5 lyophilized serum levels (1.0 mL). - Check 1: Approximate target range of ≤ 2 ng/mL - Check 2: Approximate target range of 17.5 – 22.4 ng/mL - Check 3: Approximate target range of 46.5 – 54.4 ng/mL - Check 4: Approximate target range of 75.5 – 84.4 ng/mL - Check 5: Approximate target range of 94.5 – > 100 ng/mL The labeling for above materials that contain human blood or serum matrices include the following statement: All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 Elecsys Vitamin D Assay 2. Predicate 510(k) number(s): k113546 3. Comparison with predicate: Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 Intended Use This assay is intended for the quantitative determination of total 25- hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. Same Assay Method Competition principle binding protein Same Detection Method Electrochemiluminescence Same Applications/Test Time 27 minutes Same Calibration Method 2-point calibration based on master curve for specific reagent lot Same LoB, LoD, LoQ 2 ng/mL, 3 ng/mL, 5 ng/mL Same Instrument Platform cobas e 411 Elecsys 2010, MODULAR 5 Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 Sample Type Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Traceability ID-LC-MS/MS traceable to NIST RMP 2972 LC-MS/MS Measuring Range 5 – 100.0 ng/mL 5 – 60.0 ng/mL Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 Intended Use/ CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II Same Analyte 25-hydroxyvitamin D3 25-hydroxyvitamin D Matrix Human serum matrix with added 25-hydroxyvitamin D3 Human serum matrix with added 25-hydroxyvitamin D Target Ranges Cal 1: approximately 2 ng/mL Cal 2: approximately 45 ng/mL Cal 1: approximately 2 ng/mL Cal 2: approximately 37 ng/mL Storage and Stability Reconstituted calibrators: · At 2-8°C – 72 hours · At -20°C – 12 weeks (freeze only once) · On the cobas e 411 analyzer – up to 6 hours Reconstituted calibrators: · At 2-8°C – 120 hours · At -20°C – 90 days (freeze only once) · On the cobas e 411 analyzer – up to 5 hours Calibration Interval Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 3 months (12 weeks) using the same reagent lot · After 7 days (when using Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 1 month (28 days) using the same reagent lot · After 7 days (when using 6 Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits Format Lyophilized Same Similarities and Differences for Control Item Candidate Device PreciControl Vitamin D total II k162840 Predicate device PreciControl Varia k113546 Intended Use PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay Same Analyte 25-hydroxyvitamin D Vitamin B12, Ferritin, Folate β-CTx, Osteocalcin, Parathyroid hormone Measurand:

idK162840_s0_e2000

K162840.txt

type of test

Quantitative electrochemiluminescence immunoassay

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162840 B. Purpose for Submission: New Device C. Measurand: Total 25-hydroxyvitamin D (25-OH vitamin D) D. Type of Test: Quantitative electrochemiluminescence immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Vitamin D total II Vitamin D total II CalSet PreciControl Vitamin D total II Vitamin D CalCheck G. Regulatory Information: 1. Regulation section: 1 21 CFR 862.1825, Vitamin D Test System 21 CFR 862.1150, Calibrator 21 CFR 862.1660, Quality Control Material (assayed and unassayed) 2. Classification: 2 Class II Class II Class I, reserved 3. Product code: MRG – Vitamin D Test System JIT – Calibrator, secondary JJX – Quality Control Material 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II PreciControl Vitamin D total II is used for quality control of Elecsys Vitamin D total II assay on cobas e 411 immunoassay analyzer. CalCheck Vitamin D total II 3 This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Roche Cobas e 411 analyzer I. Device Description: 1. The Elecsys Vitamin D total II reagent working solutions include: · PT1 Pretreatment reagent 1 (white cap), 1 bottle, 4 mL: Dithiothreitol 1 g/L, pH 5.5. · PT2 Pretreatment reagent 2 (gray cap), 1 bottle, 4 mL: Sodium hydroxide 28 g/L. · M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. · R1 Vitamin D binding protein‑Ru/(bpy) (gray cap), 1 bottle, 6.5 mL: Ruthenium labeled vitamin D binding protein 100 μg/L; bis‑tris propane buffer 100 mmol/L; albumin (human) 40 g/L; pH 6.4; preservative. · R2 25‑hydroxyvitamin D~biotin (black cap), 1 bottle, 6.5 mL: Biotinylated 25‑hydroxyvitamin D 140 μg/L; bis‑tris propane buffer 100 mmol/L; pH 8.6; preservative. 2. Calibrator: CalSet Vitamin D total II is a two concentration level set of lyophilized human serum . The CalSet includes Cal 1 (approximately 2 ng/mL 25-hydroxyvitamin D3 ) and Cal 2 (approximately 45 ng/mL 25-hydroxyvitamin D3). 3. Control: PreciControl Vitamin D total II materials are lyophilized human sera in two concentration ranges. Controls 1 and 2 (CTL 1 & CTL 2) are available in 1.0 mL bottles with two defined concentrations of total 25-hydroxy vitamin D The target concentrations are approximately 13 ng/mL and 30 ng/mL. 4. Calibration Verification Materials: Each set of CalCheck Vitamin D total II contains 5 lyophilized serum levels (1.0 mL). - Check 1: Approximate target range of ≤ 2 ng/mL - Check 2: Approximate target range of 17.5 – 22.4 ng/mL - Check 3: Approximate target range of 46.5 – 54.4 ng/mL - Check 4: Approximate target range of 75.5 – 84.4 ng/mL - Check 5: Approximate target range of 94.5 – > 100 ng/mL The labeling for above materials that contain human blood or serum matrices include the following statement: All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 Elecsys Vitamin D Assay 2. Predicate 510(k) number(s): k113546 3. Comparison with predicate: Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 Intended Use This assay is intended for the quantitative determination of total 25- hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. Same Assay Method Competition principle binding protein Same Detection Method Electrochemiluminescence Same Applications/Test Time 27 minutes Same Calibration Method 2-point calibration based on master curve for specific reagent lot Same LoB, LoD, LoQ 2 ng/mL, 3 ng/mL, 5 ng/mL Same Instrument Platform cobas e 411 Elecsys 2010, MODULAR 5 Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 Sample Type Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Traceability ID-LC-MS/MS traceable to NIST RMP 2972 LC-MS/MS Measuring Range 5 – 100.0 ng/mL 5 – 60.0 ng/mL Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 Intended Use/ CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II Same Analyte 25-hydroxyvitamin D3 25-hydroxyvitamin D Matrix Human serum matrix with added 25-hydroxyvitamin D3 Human serum matrix with added 25-hydroxyvitamin D Target Ranges Cal 1: approximately 2 ng/mL Cal 2: approximately 45 ng/mL Cal 1: approximately 2 ng/mL Cal 2: approximately 37 ng/mL Storage and Stability Reconstituted calibrators: · At 2-8°C – 72 hours · At -20°C – 12 weeks (freeze only once) · On the cobas e 411 analyzer – up to 6 hours Reconstituted calibrators: · At 2-8°C – 120 hours · At -20°C – 90 days (freeze only once) · On the cobas e 411 analyzer – up to 5 hours Calibration Interval Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 3 months (12 weeks) using the same reagent lot · After 7 days (when using Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 1 month (28 days) using the same reagent lot · After 7 days (when using 6 Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits Format Lyophilized Same Similarities and Differences for Control Item Candidate Device PreciControl Vitamin D total II k162840 Predicate device PreciControl Varia k113546 Intended Use PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay Same Analyte 25-hydroxyvitamin D Vitamin B12, Ferritin, Folate β-CTx, Osteocalcin, Parathyroid hormone Type of test:

idK162840_s0_e2000

K162840.txt

product code

MRG – Vitamin D Test System

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162840 B. Purpose for Submission: New Device C. Measurand: Total 25-hydroxyvitamin D (25-OH vitamin D) D. Type of Test: Quantitative electrochemiluminescence immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Vitamin D total II Vitamin D total II CalSet PreciControl Vitamin D total II Vitamin D CalCheck G. Regulatory Information: 1. Regulation section: 1 21 CFR 862.1825, Vitamin D Test System 21 CFR 862.1150, Calibrator 21 CFR 862.1660, Quality Control Material (assayed and unassayed) 2. Classification: 2 Class II Class II Class I, reserved 3. Product code: MRG – Vitamin D Test System JIT – Calibrator, secondary JJX – Quality Control Material 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II PreciControl Vitamin D total II is used for quality control of Elecsys Vitamin D total II assay on cobas e 411 immunoassay analyzer. CalCheck Vitamin D total II 3 This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Roche Cobas e 411 analyzer I. Device Description: 1. The Elecsys Vitamin D total II reagent working solutions include: · PT1 Pretreatment reagent 1 (white cap), 1 bottle, 4 mL: Dithiothreitol 1 g/L, pH 5.5. · PT2 Pretreatment reagent 2 (gray cap), 1 bottle, 4 mL: Sodium hydroxide 28 g/L. · M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. · R1 Vitamin D binding protein‑Ru/(bpy) (gray cap), 1 bottle, 6.5 mL: Ruthenium labeled vitamin D binding protein 100 μg/L; bis‑tris propane buffer 100 mmol/L; albumin (human) 40 g/L; pH 6.4; preservative. · R2 25‑hydroxyvitamin D~biotin (black cap), 1 bottle, 6.5 mL: Biotinylated 25‑hydroxyvitamin D 140 μg/L; bis‑tris propane buffer 100 mmol/L; pH 8.6; preservative. 2. Calibrator: CalSet Vitamin D total II is a two concentration level set of lyophilized human serum . The CalSet includes Cal 1 (approximately 2 ng/mL 25-hydroxyvitamin D3 ) and Cal 2 (approximately 45 ng/mL 25-hydroxyvitamin D3). 3. Control: PreciControl Vitamin D total II materials are lyophilized human sera in two concentration ranges. Controls 1 and 2 (CTL 1 & CTL 2) are available in 1.0 mL bottles with two defined concentrations of total 25-hydroxy vitamin D The target concentrations are approximately 13 ng/mL and 30 ng/mL. 4. Calibration Verification Materials: Each set of CalCheck Vitamin D total II contains 5 lyophilized serum levels (1.0 mL). - Check 1: Approximate target range of ≤ 2 ng/mL - Check 2: Approximate target range of 17.5 – 22.4 ng/mL - Check 3: Approximate target range of 46.5 – 54.4 ng/mL - Check 4: Approximate target range of 75.5 – 84.4 ng/mL - Check 5: Approximate target range of 94.5 – > 100 ng/mL The labeling for above materials that contain human blood or serum matrices include the following statement: All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 Elecsys Vitamin D Assay 2. Predicate 510(k) number(s): k113546 3. Comparison with predicate: Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 Intended Use This assay is intended for the quantitative determination of total 25- hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. Same Assay Method Competition principle binding protein Same Detection Method Electrochemiluminescence Same Applications/Test Time 27 minutes Same Calibration Method 2-point calibration based on master curve for specific reagent lot Same LoB, LoD, LoQ 2 ng/mL, 3 ng/mL, 5 ng/mL Same Instrument Platform cobas e 411 Elecsys 2010, MODULAR 5 Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 Sample Type Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Traceability ID-LC-MS/MS traceable to NIST RMP 2972 LC-MS/MS Measuring Range 5 – 100.0 ng/mL 5 – 60.0 ng/mL Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 Intended Use/ CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II Same Analyte 25-hydroxyvitamin D3 25-hydroxyvitamin D Matrix Human serum matrix with added 25-hydroxyvitamin D3 Human serum matrix with added 25-hydroxyvitamin D Target Ranges Cal 1: approximately 2 ng/mL Cal 2: approximately 45 ng/mL Cal 1: approximately 2 ng/mL Cal 2: approximately 37 ng/mL Storage and Stability Reconstituted calibrators: · At 2-8°C – 72 hours · At -20°C – 12 weeks (freeze only once) · On the cobas e 411 analyzer – up to 6 hours Reconstituted calibrators: · At 2-8°C – 120 hours · At -20°C – 90 days (freeze only once) · On the cobas e 411 analyzer – up to 5 hours Calibration Interval Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 3 months (12 weeks) using the same reagent lot · After 7 days (when using Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 1 month (28 days) using the same reagent lot · After 7 days (when using 6 Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits Format Lyophilized Same Similarities and Differences for Control Item Candidate Device PreciControl Vitamin D total II k162840 Predicate device PreciControl Varia k113546 Intended Use PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay Same Analyte 25-hydroxyvitamin D Vitamin B12, Ferritin, Folate β-CTx, Osteocalcin, Parathyroid hormone Product code:

idK162840_s0_e2000

K162840.txt

panel

Clinical Chemistry (75)

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162840 B. Purpose for Submission: New Device C. Measurand: Total 25-hydroxyvitamin D (25-OH vitamin D) D. Type of Test: Quantitative electrochemiluminescence immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Vitamin D total II Vitamin D total II CalSet PreciControl Vitamin D total II Vitamin D CalCheck G. Regulatory Information: 1. Regulation section: 1 21 CFR 862.1825, Vitamin D Test System 21 CFR 862.1150, Calibrator 21 CFR 862.1660, Quality Control Material (assayed and unassayed) 2. Classification: 2 Class II Class II Class I, reserved 3. Product code: MRG – Vitamin D Test System JIT – Calibrator, secondary JJX – Quality Control Material 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II PreciControl Vitamin D total II is used for quality control of Elecsys Vitamin D total II assay on cobas e 411 immunoassay analyzer. CalCheck Vitamin D total II 3 This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Roche Cobas e 411 analyzer I. Device Description: 1. The Elecsys Vitamin D total II reagent working solutions include: · PT1 Pretreatment reagent 1 (white cap), 1 bottle, 4 mL: Dithiothreitol 1 g/L, pH 5.5. · PT2 Pretreatment reagent 2 (gray cap), 1 bottle, 4 mL: Sodium hydroxide 28 g/L. · M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. · R1 Vitamin D binding protein‑Ru/(bpy) (gray cap), 1 bottle, 6.5 mL: Ruthenium labeled vitamin D binding protein 100 μg/L; bis‑tris propane buffer 100 mmol/L; albumin (human) 40 g/L; pH 6.4; preservative. · R2 25‑hydroxyvitamin D~biotin (black cap), 1 bottle, 6.5 mL: Biotinylated 25‑hydroxyvitamin D 140 μg/L; bis‑tris propane buffer 100 mmol/L; pH 8.6; preservative. 2. Calibrator: CalSet Vitamin D total II is a two concentration level set of lyophilized human serum . The CalSet includes Cal 1 (approximately 2 ng/mL 25-hydroxyvitamin D3 ) and Cal 2 (approximately 45 ng/mL 25-hydroxyvitamin D3). 3. Control: PreciControl Vitamin D total II materials are lyophilized human sera in two concentration ranges. Controls 1 and 2 (CTL 1 & CTL 2) are available in 1.0 mL bottles with two defined concentrations of total 25-hydroxy vitamin D The target concentrations are approximately 13 ng/mL and 30 ng/mL. 4. Calibration Verification Materials: Each set of CalCheck Vitamin D total II contains 5 lyophilized serum levels (1.0 mL). - Check 1: Approximate target range of ≤ 2 ng/mL - Check 2: Approximate target range of 17.5 – 22.4 ng/mL - Check 3: Approximate target range of 46.5 – 54.4 ng/mL - Check 4: Approximate target range of 75.5 – 84.4 ng/mL - Check 5: Approximate target range of 94.5 – > 100 ng/mL The labeling for above materials that contain human blood or serum matrices include the following statement: All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 Elecsys Vitamin D Assay 2. Predicate 510(k) number(s): k113546 3. Comparison with predicate: Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 Intended Use This assay is intended for the quantitative determination of total 25- hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. Same Assay Method Competition principle binding protein Same Detection Method Electrochemiluminescence Same Applications/Test Time 27 minutes Same Calibration Method 2-point calibration based on master curve for specific reagent lot Same LoB, LoD, LoQ 2 ng/mL, 3 ng/mL, 5 ng/mL Same Instrument Platform cobas e 411 Elecsys 2010, MODULAR 5 Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 Sample Type Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Traceability ID-LC-MS/MS traceable to NIST RMP 2972 LC-MS/MS Measuring Range 5 – 100.0 ng/mL 5 – 60.0 ng/mL Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 Intended Use/ CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II Same Analyte 25-hydroxyvitamin D3 25-hydroxyvitamin D Matrix Human serum matrix with added 25-hydroxyvitamin D3 Human serum matrix with added 25-hydroxyvitamin D Target Ranges Cal 1: approximately 2 ng/mL Cal 2: approximately 45 ng/mL Cal 1: approximately 2 ng/mL Cal 2: approximately 37 ng/mL Storage and Stability Reconstituted calibrators: · At 2-8°C – 72 hours · At -20°C – 12 weeks (freeze only once) · On the cobas e 411 analyzer – up to 6 hours Reconstituted calibrators: · At 2-8°C – 120 hours · At -20°C – 90 days (freeze only once) · On the cobas e 411 analyzer – up to 5 hours Calibration Interval Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 3 months (12 weeks) using the same reagent lot · After 7 days (when using Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 1 month (28 days) using the same reagent lot · After 7 days (when using 6 Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits Format Lyophilized Same Similarities and Differences for Control Item Candidate Device PreciControl Vitamin D total II k162840 Predicate device PreciControl Varia k113546 Intended Use PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay Same Analyte 25-hydroxyvitamin D Vitamin B12, Ferritin, Folate β-CTx, Osteocalcin, Parathyroid hormone Panel:

idK162840_s0_e2000

K162840.txt

intended use

See indications for use below.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162840 B. Purpose for Submission: New Device C. Measurand: Total 25-hydroxyvitamin D (25-OH vitamin D) D. Type of Test: Quantitative electrochemiluminescence immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Vitamin D total II Vitamin D total II CalSet PreciControl Vitamin D total II Vitamin D CalCheck G. Regulatory Information: 1. Regulation section: 1 21 CFR 862.1825, Vitamin D Test System 21 CFR 862.1150, Calibrator 21 CFR 862.1660, Quality Control Material (assayed and unassayed) 2. Classification: 2 Class II Class II Class I, reserved 3. Product code: MRG – Vitamin D Test System JIT – Calibrator, secondary JJX – Quality Control Material 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II PreciControl Vitamin D total II is used for quality control of Elecsys Vitamin D total II assay on cobas e 411 immunoassay analyzer. CalCheck Vitamin D total II 3 This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Roche Cobas e 411 analyzer I. Device Description: 1. The Elecsys Vitamin D total II reagent working solutions include: · PT1 Pretreatment reagent 1 (white cap), 1 bottle, 4 mL: Dithiothreitol 1 g/L, pH 5.5. · PT2 Pretreatment reagent 2 (gray cap), 1 bottle, 4 mL: Sodium hydroxide 28 g/L. · M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. · R1 Vitamin D binding protein‑Ru/(bpy) (gray cap), 1 bottle, 6.5 mL: Ruthenium labeled vitamin D binding protein 100 μg/L; bis‑tris propane buffer 100 mmol/L; albumin (human) 40 g/L; pH 6.4; preservative. · R2 25‑hydroxyvitamin D~biotin (black cap), 1 bottle, 6.5 mL: Biotinylated 25‑hydroxyvitamin D 140 μg/L; bis‑tris propane buffer 100 mmol/L; pH 8.6; preservative. 2. Calibrator: CalSet Vitamin D total II is a two concentration level set of lyophilized human serum . The CalSet includes Cal 1 (approximately 2 ng/mL 25-hydroxyvitamin D3 ) and Cal 2 (approximately 45 ng/mL 25-hydroxyvitamin D3). 3. Control: PreciControl Vitamin D total II materials are lyophilized human sera in two concentration ranges. Controls 1 and 2 (CTL 1 & CTL 2) are available in 1.0 mL bottles with two defined concentrations of total 25-hydroxy vitamin D The target concentrations are approximately 13 ng/mL and 30 ng/mL. 4. Calibration Verification Materials: Each set of CalCheck Vitamin D total II contains 5 lyophilized serum levels (1.0 mL). - Check 1: Approximate target range of ≤ 2 ng/mL - Check 2: Approximate target range of 17.5 – 22.4 ng/mL - Check 3: Approximate target range of 46.5 – 54.4 ng/mL - Check 4: Approximate target range of 75.5 – 84.4 ng/mL - Check 5: Approximate target range of 94.5 – > 100 ng/mL The labeling for above materials that contain human blood or serum matrices include the following statement: All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 Elecsys Vitamin D Assay 2. Predicate 510(k) number(s): k113546 3. Comparison with predicate: Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 Intended Use This assay is intended for the quantitative determination of total 25- hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. Same Assay Method Competition principle binding protein Same Detection Method Electrochemiluminescence Same Applications/Test Time 27 minutes Same Calibration Method 2-point calibration based on master curve for specific reagent lot Same LoB, LoD, LoQ 2 ng/mL, 3 ng/mL, 5 ng/mL Same Instrument Platform cobas e 411 Elecsys 2010, MODULAR 5 Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 Sample Type Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Traceability ID-LC-MS/MS traceable to NIST RMP 2972 LC-MS/MS Measuring Range 5 – 100.0 ng/mL 5 – 60.0 ng/mL Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 Intended Use/ CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II Same Analyte 25-hydroxyvitamin D3 25-hydroxyvitamin D Matrix Human serum matrix with added 25-hydroxyvitamin D3 Human serum matrix with added 25-hydroxyvitamin D Target Ranges Cal 1: approximately 2 ng/mL Cal 2: approximately 45 ng/mL Cal 1: approximately 2 ng/mL Cal 2: approximately 37 ng/mL Storage and Stability Reconstituted calibrators: · At 2-8°C – 72 hours · At -20°C – 12 weeks (freeze only once) · On the cobas e 411 analyzer – up to 6 hours Reconstituted calibrators: · At 2-8°C – 120 hours · At -20°C – 90 days (freeze only once) · On the cobas e 411 analyzer – up to 5 hours Calibration Interval Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 3 months (12 weeks) using the same reagent lot · After 7 days (when using Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 1 month (28 days) using the same reagent lot · After 7 days (when using 6 Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits Format Lyophilized Same Similarities and Differences for Control Item Candidate Device PreciControl Vitamin D total II k162840 Predicate device PreciControl Varia k113546 Intended Use PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay Same Analyte 25-hydroxyvitamin D Vitamin B12, Ferritin, Folate β-CTx, Osteocalcin, Parathyroid hormone Intended use:

idK162840_s0_e2000

K162840.txt

predicate device name

Elecsys Vitamin D Assay

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162840 B. Purpose for Submission: New Device C. Measurand: Total 25-hydroxyvitamin D (25-OH vitamin D) D. Type of Test: Quantitative electrochemiluminescence immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Vitamin D total II Vitamin D total II CalSet PreciControl Vitamin D total II Vitamin D CalCheck G. Regulatory Information: 1. Regulation section: 1 21 CFR 862.1825, Vitamin D Test System 21 CFR 862.1150, Calibrator 21 CFR 862.1660, Quality Control Material (assayed and unassayed) 2. Classification: 2 Class II Class II Class I, reserved 3. Product code: MRG – Vitamin D Test System JIT – Calibrator, secondary JJX – Quality Control Material 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II PreciControl Vitamin D total II is used for quality control of Elecsys Vitamin D total II assay on cobas e 411 immunoassay analyzer. CalCheck Vitamin D total II 3 This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Roche Cobas e 411 analyzer I. Device Description: 1. The Elecsys Vitamin D total II reagent working solutions include: · PT1 Pretreatment reagent 1 (white cap), 1 bottle, 4 mL: Dithiothreitol 1 g/L, pH 5.5. · PT2 Pretreatment reagent 2 (gray cap), 1 bottle, 4 mL: Sodium hydroxide 28 g/L. · M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. · R1 Vitamin D binding protein‑Ru/(bpy) (gray cap), 1 bottle, 6.5 mL: Ruthenium labeled vitamin D binding protein 100 μg/L; bis‑tris propane buffer 100 mmol/L; albumin (human) 40 g/L; pH 6.4; preservative. · R2 25‑hydroxyvitamin D~biotin (black cap), 1 bottle, 6.5 mL: Biotinylated 25‑hydroxyvitamin D 140 μg/L; bis‑tris propane buffer 100 mmol/L; pH 8.6; preservative. 2. Calibrator: CalSet Vitamin D total II is a two concentration level set of lyophilized human serum . The CalSet includes Cal 1 (approximately 2 ng/mL 25-hydroxyvitamin D3 ) and Cal 2 (approximately 45 ng/mL 25-hydroxyvitamin D3). 3. Control: PreciControl Vitamin D total II materials are lyophilized human sera in two concentration ranges. Controls 1 and 2 (CTL 1 & CTL 2) are available in 1.0 mL bottles with two defined concentrations of total 25-hydroxy vitamin D The target concentrations are approximately 13 ng/mL and 30 ng/mL. 4. Calibration Verification Materials: Each set of CalCheck Vitamin D total II contains 5 lyophilized serum levels (1.0 mL). - Check 1: Approximate target range of ≤ 2 ng/mL - Check 2: Approximate target range of 17.5 – 22.4 ng/mL - Check 3: Approximate target range of 46.5 – 54.4 ng/mL - Check 4: Approximate target range of 75.5 – 84.4 ng/mL - Check 5: Approximate target range of 94.5 – > 100 ng/mL The labeling for above materials that contain human blood or serum matrices include the following statement: All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 Elecsys Vitamin D Assay 2. Predicate 510(k) number(s): k113546 3. Comparison with predicate: Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 Intended Use This assay is intended for the quantitative determination of total 25- hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. Same Assay Method Competition principle binding protein Same Detection Method Electrochemiluminescence Same Applications/Test Time 27 minutes Same Calibration Method 2-point calibration based on master curve for specific reagent lot Same LoB, LoD, LoQ 2 ng/mL, 3 ng/mL, 5 ng/mL Same Instrument Platform cobas e 411 Elecsys 2010, MODULAR 5 Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 Sample Type Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Traceability ID-LC-MS/MS traceable to NIST RMP 2972 LC-MS/MS Measuring Range 5 – 100.0 ng/mL 5 – 60.0 ng/mL Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 Intended Use/ CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II Same Analyte 25-hydroxyvitamin D3 25-hydroxyvitamin D Matrix Human serum matrix with added 25-hydroxyvitamin D3 Human serum matrix with added 25-hydroxyvitamin D Target Ranges Cal 1: approximately 2 ng/mL Cal 2: approximately 45 ng/mL Cal 1: approximately 2 ng/mL Cal 2: approximately 37 ng/mL Storage and Stability Reconstituted calibrators: · At 2-8°C – 72 hours · At -20°C – 12 weeks (freeze only once) · On the cobas e 411 analyzer – up to 6 hours Reconstituted calibrators: · At 2-8°C – 120 hours · At -20°C – 90 days (freeze only once) · On the cobas e 411 analyzer – up to 5 hours Calibration Interval Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 3 months (12 weeks) using the same reagent lot · After 7 days (when using Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 1 month (28 days) using the same reagent lot · After 7 days (when using 6 Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits Format Lyophilized Same Similarities and Differences for Control Item Candidate Device PreciControl Vitamin D total II k162840 Predicate device PreciControl Varia k113546 Intended Use PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay Same Analyte 25-hydroxyvitamin D Vitamin B12, Ferritin, Folate β-CTx, Osteocalcin, Parathyroid hormone Predicate device name:

idK162840_s0_e2000

K162840.txt

applicant

Roche Diagnostics

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162840 B. Purpose for Submission: New Device C. Measurand: Total 25-hydroxyvitamin D (25-OH vitamin D) D. Type of Test: Quantitative electrochemiluminescence immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Vitamin D total II Vitamin D total II CalSet PreciControl Vitamin D total II Vitamin D CalCheck G. Regulatory Information: 1. Regulation section: 1 21 CFR 862.1825, Vitamin D Test System 21 CFR 862.1150, Calibrator 21 CFR 862.1660, Quality Control Material (assayed and unassayed) 2. Classification: 2 Class II Class II Class I, reserved 3. Product code: MRG – Vitamin D Test System JIT – Calibrator, secondary JJX – Quality Control Material 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II PreciControl Vitamin D total II is used for quality control of Elecsys Vitamin D total II assay on cobas e 411 immunoassay analyzer. CalCheck Vitamin D total II 3 This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Roche Cobas e 411 analyzer I. Device Description: 1. The Elecsys Vitamin D total II reagent working solutions include: · PT1 Pretreatment reagent 1 (white cap), 1 bottle, 4 mL: Dithiothreitol 1 g/L, pH 5.5. · PT2 Pretreatment reagent 2 (gray cap), 1 bottle, 4 mL: Sodium hydroxide 28 g/L. · M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. · R1 Vitamin D binding protein‑Ru/(bpy) (gray cap), 1 bottle, 6.5 mL: Ruthenium labeled vitamin D binding protein 100 μg/L; bis‑tris propane buffer 100 mmol/L; albumin (human) 40 g/L; pH 6.4; preservative. · R2 25‑hydroxyvitamin D~biotin (black cap), 1 bottle, 6.5 mL: Biotinylated 25‑hydroxyvitamin D 140 μg/L; bis‑tris propane buffer 100 mmol/L; pH 8.6; preservative. 2. Calibrator: CalSet Vitamin D total II is a two concentration level set of lyophilized human serum . The CalSet includes Cal 1 (approximately 2 ng/mL 25-hydroxyvitamin D3 ) and Cal 2 (approximately 45 ng/mL 25-hydroxyvitamin D3). 3. Control: PreciControl Vitamin D total II materials are lyophilized human sera in two concentration ranges. Controls 1 and 2 (CTL 1 & CTL 2) are available in 1.0 mL bottles with two defined concentrations of total 25-hydroxy vitamin D The target concentrations are approximately 13 ng/mL and 30 ng/mL. 4. Calibration Verification Materials: Each set of CalCheck Vitamin D total II contains 5 lyophilized serum levels (1.0 mL). - Check 1: Approximate target range of ≤ 2 ng/mL - Check 2: Approximate target range of 17.5 – 22.4 ng/mL - Check 3: Approximate target range of 46.5 – 54.4 ng/mL - Check 4: Approximate target range of 75.5 – 84.4 ng/mL - Check 5: Approximate target range of 94.5 – > 100 ng/mL The labeling for above materials that contain human blood or serum matrices include the following statement: All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 Elecsys Vitamin D Assay 2. Predicate 510(k) number(s): k113546 3. Comparison with predicate: Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 Intended Use This assay is intended for the quantitative determination of total 25- hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. Same Assay Method Competition principle binding protein Same Detection Method Electrochemiluminescence Same Applications/Test Time 27 minutes Same Calibration Method 2-point calibration based on master curve for specific reagent lot Same LoB, LoD, LoQ 2 ng/mL, 3 ng/mL, 5 ng/mL Same Instrument Platform cobas e 411 Elecsys 2010, MODULAR 5 Similarities and Differences for Assay Item Candidate Device Elecsys Vitamin D total II k162840 Predicate device Elecsys Vitamin D Assay k113546 ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 Sample Type Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Serum and Li-heparin, K2- EDTA, K3-EDTA, Plasma Gel Seperation tubes (Li- Heparin) Traceability ID-LC-MS/MS traceable to NIST RMP 2972 LC-MS/MS Measuring Range 5 – 100.0 ng/mL 5 – 60.0 ng/mL Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 Intended Use/ CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II Same Analyte 25-hydroxyvitamin D3 25-hydroxyvitamin D Matrix Human serum matrix with added 25-hydroxyvitamin D3 Human serum matrix with added 25-hydroxyvitamin D Target Ranges Cal 1: approximately 2 ng/mL Cal 2: approximately 45 ng/mL Cal 1: approximately 2 ng/mL Cal 2: approximately 37 ng/mL Storage and Stability Reconstituted calibrators: · At 2-8°C – 72 hours · At -20°C – 12 weeks (freeze only once) · On the cobas e 411 analyzer – up to 6 hours Reconstituted calibrators: · At 2-8°C – 120 hours · At -20°C – 90 days (freeze only once) · On the cobas e 411 analyzer – up to 5 hours Calibration Interval Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 3 months (12 weeks) using the same reagent lot · After 7 days (when using Calibration must be performed once per reagent lot using fresh reagent (< 24 hours since registered). Renewed calibration: · After 1 month (28 days) using the same reagent lot · After 7 days (when using 6 Similarities and Differences for Calibrator Item Candidate Device CalSet Vitamin D total II k162840 Predicate device Vitamin D CalSet k113546 the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits the same reagent kit on the analyzer) · As required e.g. quality control findings outside the defined limits Format Lyophilized Same Similarities and Differences for Control Item Candidate Device PreciControl Vitamin D total II k162840 Predicate device PreciControl Varia k113546 Intended Use PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay Same Analyte 25-hydroxyvitamin D Vitamin B12, Ferritin, Folate β-CTx, Osteocalcin, Parathyroid hormone Applicant:

idK162840_s6000_e8000

K162840.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

concentrations of 25, 40, and 60 ng/mL, and analyzed with the Elecsys Vitamin D total II assay on the cobas e 411analyzer. Results from the spiked serum samples were matched against the unspiked references and the % cross-reactivity was calculated using the equation below. % Cross-Reactivity= mean value spiked –mean value unspiked X 100 15 Spiked Concentration Cross-reactant Concentration of spiked cross reactants (ng/mL) Non – Normalized Mean Cross Reactivity % Normalized Mean Cross Reactivity % 25-hydroxy Vitamin D2 50 84.0 93.7 25-hydroxy Vitamin D3 50 89.8 100 24,25-dihydroxy Vitamin D3 100 12.4 13.7 3-epi 25-hydroxy Vitamin D3 50 101.5 112.8 3-epi 25-hydroxy Vitamin D2 50 82.3 91.4 1,25-dihydroxy Vitamin D3 100 Not detected Not detected 1,25-dihydroxy Vitamin D2 100 Not detected Not detected Vitamin D3(Cholecalciferol) 1000 0.6 0.7 Vitamin D2(Ergocalciferol) 1000 0.2 0.3 To reflect the endogenous situation and binding behavior of the metabolite without spiking effect and to avoid potentially underreporting the cross-reactivity to 25- hydroxy Vitamin D2, the observed % cross-reactivities shown above were normalized to 25-hydroxyvitamin D3 by dividing the respective observed % cross- reactivity by the % cross-reactivity of 25-hydroxyvitamin D3. The table above shows the mean % cross-reactivity for both normalized and non-normalized samples. High Dose Hook Effect: The high-dose hook effect of the Elecsys Vitamin D total II assay was assessed on the cobas e 411 analyzer. One human serum sample was spiked with analyte to achieve a high 25-OH Vitamin D concentration of approximatly10,000 ng/mL. A dilution series was performed using a low level analyte (Vitamin D depleted) serum. The study results show that no hook effect was observed up to 10,000 ng/mL for Elecsys Vitamin D total II. f. Assay cut-off: Not applicable 2. Comparison studies: 16 a. Method Comparison to Reference Method: A method comparison study against the ID-LC-MS/MS 25(OH)D Reference Measurement Procedure (RMP) was the basis of the substantial equivalence determination for this submission. A method comparison study to compare the candidate device Elcsys Vitamin D total II with Reference method ID-LC-MS/MS method using a total of 111 native single donor patient serum samples (provided by the Vitamin D Standardization and Certification Program with assigned values by the RMP at CDC, independent from the samples used for standardization) were measured in singleton on the cobas e 411 analyzer. The 25-hydroxyvitamin D values ranged between 5.64 and 92.8 ng/mL as measured by the Reference Method, LC-MS/MS. The results are summarized in the table below: Deming regression results n 111 Slope 0.954 Intercept -0.707 Correlation Coefficient 0.982 Range(ng/mL) 5.64-92.8 b. Method comparison with predicate device: A method comparison was performed using the candidate Elecsys Vitamin D total II assay and the predicate Elecsys Vitamin D Assay to assess the bias between the two assays. A total of 105 single native donors serum samples were measured in singleton on the cobas e 411 analyzer in one run covering the entire measuring range of the predicate device. The results are summarized in the table below: Deming regression results n 105 Slope 0.849 Intercept 0.983 Correlation Coefficient 0.955 Range(ng/mL) 6.1-56 c. Matrix comparison: The effect on quantitation of 25-OH Vitamin D with the Elecsys Vitamin D total II assay in the presence of different anticoagulants was determined by comparing values obtained from samples (single donors - native, diluted as well as spiked) drawn into serum, Li-Heparin, K2-EDTA, K3-EDTA plasma primary tubes, and Plasma Gel Separation Tubes (Li-Heparin). A minimum of 45 serum/plasma pairs per sample material were tested in singleton with one reagent lot on one cobas e 411 immunoassay analyzer. The linear regression equations from the comparisons are given below: Serum/Li-Heparin Plasma Comparison: y = 0.984x - 0.0.10, r = 0.997 Serum/K2- EDTA Plasma Comparison: y = 0.981x - 0.341, r = 0.998 Serum/K3- EDTA Plasma Comparison: y =0.992x -1.25, r = 0.998 Serum/Li-Heparin Plasma Gel Separation Tubes Comparison: y = 0.974x + 0.735, r = 0.999 The data support the package insert claim that serum, Li-Heparin, K2-EDTA and K3- EDTA-plasma as well as Li-Heparin Plasma Gel Separation Tubes are acceptable sample types for use with Elecsys Vitamin D total II. 3. Clinical studies: 17 a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The reference range study was conducted with reference to the CLSI C28-A3 guideline. Total of 421 serum samples from 50% males and 50% females, with 30% dark skin tone were collected from apparently healthy adults, from 21 to 88 years old. The samples were collected from three regionally diverse U.S regions during the summer and winter seasons (approximately 50% summer and 50% winter time) to represent a broad spectrum of UV light exposure in the intended use population. The samples were assayed on the cobas e 411 immunoassay analyzer. The Reference Interval for the total population of the study for the Elecsys Vitamin D total II assay was calculated using the 95% Reference Interval (2.5th to 97.5th percentile). Normal Adults: 7.61 – 55.5 ng/mL (n= 421). N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 18 Proposed labeling:

idK162840_s6000_e8000

K162840.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

itamin D concentrations of 25, 40, and 60 ng/mL, and analyzed with the Elecsys Vitamin D total II assay on the cobas e 411analyzer. Results from the spiked serum samples were matched against the unspiked references and the % cross-reactivity was calculated using the equation below. % Cross-Reactivity= mean value spiked –mean value unspiked X 100 15 Spiked Concentration Cross-reactant Concentration of spiked cross reactants (ng/mL) Non – Normalized Mean Cross Reactivity % Normalized Mean Cross Reactivity % 25-hydroxy Vitamin D2 50 84.0 93.7 25-hydroxy Vitamin D3 50 89.8 100 24,25-dihydroxy Vitamin D3 100 12.4 13.7 3-epi 25-hydroxy Vitamin D3 50 101.5 112.8 3-epi 25-hydroxy Vitamin D2 50 82.3 91.4 1,25-dihydroxy Vitamin D3 100 Not detected Not detected 1,25-dihydroxy Vitamin D2 100 Not detected Not detected Vitamin D3(Cholecalciferol) 1000 0.6 0.7 Vitamin D2(Ergocalciferol) 1000 0.2 0.3 To reflect the endogenous situation and binding behavior of the metabolite without spiking effect and to avoid potentially underreporting the cross-reactivity to 25- hydroxy Vitamin D2, the observed % cross-reactivities shown above were normalized to 25-hydroxyvitamin D3 by dividing the respective observed % cross- reactivity by the % cross-reactivity of 25-hydroxyvitamin D3. The table above shows the mean % cross-reactivity for both normalized and non-normalized samples. High Dose Hook Effect: The high-dose hook effect of the Elecsys Vitamin D total II assay was assessed on the cobas e 411 analyzer. One human serum sample was spiked with analyte to achieve a high 25-OH Vitamin D concentration of approximatly10,000 ng/mL. A dilution series was performed using a low level analyte (Vitamin D depleted) serum. The study results show that no hook effect was observed up to 10,000 ng/mL for Elecsys Vitamin D total II. f. Assay cut-off: Not applicable 2. Comparison studies: 16 a. Method Comparison to Reference Method: A method comparison study against the ID-LC-MS/MS 25(OH)D Reference Measurement Procedure (RMP) was the basis of the substantial equivalence determination for this submission. A method comparison study to compare the candidate device Elcsys Vitamin D total II with Reference method ID-LC-MS/MS method using a total of 111 native single donor patient serum samples (provided by the Vitamin D Standardization and Certification Program with assigned values by the RMP at CDC, independent from the samples used for standardization) were measured in singleton on the cobas e 411 analyzer. The 25-hydroxyvitamin D values ranged between 5.64 and 92.8 ng/mL as measured by the Reference Method, LC-MS/MS. The results are summarized in the table below: Deming regression results n 111 Slope 0.954 Intercept -0.707 Correlation Coefficient 0.982 Range(ng/mL) 5.64-92.8 b. Method comparison with predicate device: A method comparison was performed using the candidate Elecsys Vitamin D total II assay and the predicate Elecsys Vitamin D Assay to assess the bias between the two assays. A total of 105 single native donors serum samples were measured in singleton on the cobas e 411 analyzer in one run covering the entire measuring range of the predicate device. The results are summarized in the table below: Deming regression results n 105 Slope 0.849 Intercept 0.983 Correlation Coefficient 0.955 Range(ng/mL) 6.1-56 c. Matrix comparison: The effect on quantitation of 25-OH Vitamin D with the Elecsys Vitamin D total II assay in the presence of different anticoagulants was determined by comparing values obtained from samples (single donors - native, diluted as well as spiked) drawn into serum, Li-Heparin, K2-EDTA, K3-EDTA plasma primary tubes, and Plasma Gel Separation Tubes (Li-Heparin). A minimum of 45 serum/plasma pairs per sample material were tested in singleton with one reagent lot on one cobas e 411 immunoassay analyzer. The linear regression equations from the comparisons are given below: Serum/Li-Heparin Plasma Comparison: y = 0.984x - 0.0.10, r = 0.997 Serum/K2- EDTA Plasma Comparison: y = 0.981x - 0.341, r = 0.998 Serum/K3- EDTA Plasma Comparison: y =0.992x -1.25, r = 0.998 Serum/Li-Heparin Plasma Gel Separation Tubes Comparison: y = 0.974x + 0.735, r = 0.999 The data support the package insert claim that serum, Li-Heparin, K2-EDTA and K3- EDTA-plasma as well as Li-Heparin Plasma Gel Separation Tubes are acceptable sample types for use with Elecsys Vitamin D total II. 3. Clinical studies: 17 a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The reference range study was conducted with reference to the CLSI C28-A3 guideline. Total of 421 serum samples from 50% males and 50% females, with 30% dark skin tone were collected from apparently healthy adults, from 21 to 88 years old. The samples were collected from three regionally diverse U.S regions during the summer and winter seasons (approximately 50% summer and 50% winter time) to represent a broad spectrum of UV light exposure in the intended use population. The samples were assayed on the cobas e 411 immunoassay analyzer. The Reference Interval for the total population of the study for the Elecsys Vitamin D total II assay was calculated using the 95% Reference Interval (2.5th to 97.5th percentile). Normal Adults: 7.61 – 55.5 ng/mL (n= 421). N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 18 Conclusion:

idK162526_s0_e2000

K162526.txt

purpose for submission

New device

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Purpose for submission:

idK162526_s0_e2000

K162526.txt

measurand

Creatine kinase MB subunit

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Measurand:

idK162526_s0_e2000

K162526.txt

type of test

Quantitative, enzymatic assay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Type of test:

idK162526_s0_e2000

K162526.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Classification:

idK162526_s0_e2000

K162526.txt

product code

JHW, U.V. Method, Cpk Isoenzymes

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Product code:

idK162526_s0_e2000

K162526.txt

panel

Clinical Chemistry (75)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Panel:

idK162526_s0_e2000

K162526.txt

intended use

See Indications for use below.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Intended use:

idK162526_s0_e2000

K162526.txt

indications for use

The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Indications for use:

idK162526_s0_e2000

K162526.txt

predicate device name

Roche CK-MB

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Predicate device name:

idK162526_s0_e2000

K162526.txt

applicant

Roche Diagnostics

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Applicant:

idK162526_s0_e2000

K162526.txt

proprietary and established names

Creatine Kinase-MB

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Proprietary and established names:

idK162526_s0_e2000

K162526.txt

regulation section

21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162526 B. Purpose for Submission: New device C. Measurand: Creatine kinase MB subunit D. Type of Test: Quantitative, enzymatic assay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Creatine Kinase-MB G. Regulatory Information: 1. Regulation section: 21 CFR 862.1215, Creatine phosphokinase/creatine kinase or isoenzymes test system 2. Classification: Class II 3. Product code: JHW, U.V. Method, Cpk Isoenzymes 4. Panel: Clinical Chemistry (75) 2 H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The Creatine Kinase-MB assay is an in vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Studies were performed using the Roche cobas c501 chemistry analyzer. I. Device Description: The Creatine Kinase-MB assay consists of two reagents: · R1 Imidazole buffer: 123 mmol/L, pH 6.5 (37 °C); EDTA: 2.46 mmol/L; Mg2+: 12.3 mmol/L; ADP: 2.46 mmol/L; AMP: 6.14 mmol/L; diadenosine pentaphosphate: 19 μmol/L; NADP (yeast): 2.46 mmol/L; N-acetylcysteine: 24.6 mmol/L; HK (yeast): ≥ 36.7 μkat/L; G6P-DH (E. coli): ≥ 23.4 μkat/L; preservative; stabilizers; additives. · R2 CAPSO buffer: 20 mmol/L, pH 8.8 (37 °C); glucose: 120 mmol/L; EDTA: 2.46 mmol/L; creatine phosphate: 184 mmol/L; 4 monoclonal anti-CK-M antibodies (mouse), inhibiting capacity: > 99.6 % up to 66.8 μkat/L (4000 U/L) (37 °C) CK-M subunit; preservative; stabilizers; additive. J. Substantial Equivalence Information: 1. Predicate device name(s): Roche CK-MB 3 2. Predicate 510(k) number(s): k003158 3. Comparison with predicate: Similarities Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Intended Use In vitro quantitative determination of creatine kinase MB isoenzyme in human serum and plasma. Same Sample Type/Matrix Serum and plasma Same Traceability/ Standardization Traceable to the IFCC CK method Same Differences Item Predicate CK-MB (k003158) Candidate Device Creatine kinase-MB Reagent Composition R1 Imidazole buffer and R2 CAPSO buffer. R1 Imidazole buffer (different HK (yeast) and G6PDH concentrations) and R2 CAPSO buffer. Additives have been added to both buffers. Reagent On-Board Stability 28 days opened and refrigerated on the analyzer 8 weeks on-board in use and refrigerated on the analyzer Measuring Range 5 – 2300 U/L (0.08 – 38.4 μkat/L) 10 – 2000 U/L (0.08-33.4 μkat/L) Detection Limits LDL = 5 U/L Limit of Blank = 3 U/L (0.05 μkat/L) Limit of Detection = 3 U/L (0.05 μkat/L) Limit of Quantitation = 10 U/L (0.08 μkat/L) K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. · CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. · CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline. 4 L. Test Principle: Creatine kinase (CK) catalyzes the dephosphorylation of creatine phosphate, generating ATP from ADP. Glucose is then phosphorylated by the ATP formed in the previous reaction to form D-glucose-6-phosphate (G6P), a process catalyzed by hexokinase (HK). Finally, D- glucose-6-phosphate dehydrogenase (G6PDH) catalyzes the oxidation of G6P by NADP to form D-6-phosphogluconate and NADPH. The rate of NADPH formation, determined by measuring the increase in absorbance photometrically, is directly proportional to catalytic CK activity. Human CK-MB is composed of two subunits, CK-M and CK-B which both have an active site. With the aid of specific antibodies to CK-M, the catalytic activity of CK-M subunits in the sample is inhibited to 99.6 % without affecting the CK-B subunits. The remaining CK-B activity, corresponding to half the CK-MB activity, is determined by the total CK method. As the CK-BB isoenzyme only rarely appears in serum and the catalytic activity of the CK-M and CK-B subunits hardly differ, the catalytic activity of the CK-MB isoenzyme can be calculated from the measured CK-B activity by multiplying the result by 2. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision experiments were performed in accordance with the CLSI Guideline EP5- A3. Five serum samples and 2 control levels were tested using 2 aliquots per run and 2 runs per day for > 21 days on the same cobas c 501 analyzer using 3 reagent lots. Repeatability (within run precision) and intermediate precision (within lab/within device precision incorporating run-to-run and day-to-day precision) were calculated. Precision results for the combined lots are shown below. Within-run precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.9 0.4 2.2 Human Serum 2 29.1 0.4 1.2 Human Serum 3 524 2.5 0.5 Human Serum 4 1040 4.9 0.5 Human Serum 5 1826 25 1.3 PreciControl ClinChem Multi 1 41.0 0.3 0.8 PreciControl ClinChem Multi 2 99.2 0.5 0.5 5 Within-lab precision: Specimen Mean (U/L) SD (U/L) CV (%) Human Serum 1 17.8 0.5 2.8 Human Serum 2 29.0 0.6 1.9 Human Serum 3 531 4.4 0.8 Human Serum 4 1040 8.4 0.8 Human Serum 5 1851 42 2.3 PreciControl ClinChem Multi 1 40.2 0.7 1.7 PreciControl ClinChem Multi 2 98.7 1.5 1.5 b. Linearity/assay reportable range: A linearity study was conducted according to CLSI guideline EP6-A. A dilution series was prepared using human sample pools (one serum pool and one plasma pool) with CK-MB concentrations to cover the claimed measuring range. The ranges tested were 0.4 to 2203.6 U/L for serum and 0.7 to 2709.3 U/L for plasma. Dilutions were made using 0.9% NaCl. The dilution series contains 16 concentrations for serum and 18 concentrations for plasma. Samples were measured in triplicate on a cobas c 501 analyzer and data analysis was done separately for each sample. An assessment of linearity was performed using polynomial regression analysis for 1st, 2nd, and 3rd order polynomials. The Creatine Kinase-MB test results were plotted against the expected concentrations. Analysis of the regression coefficients (using a significance level of 5%) showed that the nonlinear coefficients in both the second and third order were significant. The 3rd order was determined to have the best fit (smaller RootMSE) and was used for the calculation of deviation from linearity. The deviation from linearity met the pre-defined acceptance criterion and was within 7%. The claimed measuring range for CK-MB is 10 to 2000 U/L for serum and plasma. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: This method has been standardized against the IFCC Method for Creat Regulation section:

idK162526_s2000_e4000

K162526.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

of antibodies. Stability: The reagent shelf life stability claim is 12 months at 2-8°C. The reagent onboard (in use and refrigerated) stability claim is 8 weeks. The protocols were reviewed and found acceptable. Calibrator: The calibrator used with the CK-MB assay is the previously cleared Roche Diagnostics Calibrator for Automated Systems (k101456). 6 d. Detection limit: Limits of detection studies followed the guidelines in CLSI EP17-A2. The Limit of Blank (LoB) was determined as the 95th percentile of measurements of blank samples. The LoB calculation was performed with one analyte-free sample measured in 10 replicates with 3 reagent lots over 6 runs, 3 days, and on one cobas c 501 analyzer. In total, 60 measurements were obtained per lot. Data analysis is based on determination of the 95th percentile of the 60 measured values. The Limit of Detection (LoD) was defined as the lowest amount of analyte in a sample detected with a 95% probability. For determination of LoD, five human serum samples with low analyte concentrations (approximately up to 4 times the LoB) were run in duplicate with 3 reagent lots over 6 runs, 3 days, and on one cobas c 501 analyzer. In total, 60 measurements were obtained per lot. LoD was determined using the following equation: LoD = LoB + 1.653 × SDtot. The Limit of Quantitation (LoQ) is defined as the lowest analyte concentration that can be quantified with a %CV of no more than 20%. For determination of LoQ, a low level sample set was prepared by diluting 5 human serum samples with an analyte free diluent (0.9% NaCl). The low level sample set was tested in 5 replicates per sample on 5 days, one run per day on one cobas c 501 analyzer. The results of the evaluation of the detection limits for one representative reagent lot and the final claim are in the table below. Reagent Lot 2 (U/L) Claim (U/L) Limit of Blank 0.3 3 Limit of Detection 1.0 3 Limit of Quantitation 1.9 10 e. Analytical specificity: Endogenous interference: The effects of interference by hemoglobin, lipemia (Intralipid), and bilirubin on the CK-MB test system was determined on the cobas c 501 analyzer using pooled human serum samples with 2 CK-MB levels (Level 1: ~18 U/L, Level 2: ~1180 U/L) and spiked with varying levels of interferent. The resulting sample series (10 interferent levels per sample) were tested in triplicate and the mean values were used to calculate % recovery, by comparing the measured concentration to the expected concentration (i.e. CK-MB concentration when no interferent is added). A compound was identified as an interferent if the difference between the spiked test sample and the reference sample was >10%. The results are shown in the table below. 7 Interferent No interference up to: Information in the labeling Conjugated Bilirubin Level 1: 76 I Index Level 2: 76 I Index No significant interference up to an I index of 60 for conjugated and 20 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 60 mg/dL and approximate unconjugated bilirubin concentration: 20 mg/dL). Unconjugated Bilirubin Level 1: 28 I Index Level 2: 67 I Index Lipemia Level 1: 753 L Index Level 2: 632 L Index No significant interference up to an L index of 500. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration. Choose diluted sample treatment for automatic rerun. Hemolysis interferes with the assay. The labeling states; Do not use hemolyzed samples. Exogenous Interference: Two serum sample pools containing 2 levels of CK-MB (Level 1: ~22 U/L, Level 2: ~1065 U/L) were divided into aliquots. The concentration of an unspiked aliquot, used as a reference sample, was determined in triplicate on a cobas c501 analyzer. The other sample aliquots were spiked with the respective amount of drug and their CK-MB concentrations determined in triplicate. The means of the triplicate determinations for spiked samples and the reference were compared. A drug was identified as an interferent if the difference between the spiked test sample and the reference sample was >10%. No interference was observed in the presence of Acetylcysteine (1660 mg/L), Ampicillin-Na (1000 mg/L), Ascorbic acid (300 mg/L), Cyclosporine (5 mg/L), Heparin (5000 U), Levodopa (20 mg/L), Methyldopa +1.5 (20 mg/L), Metronidazole (200 mg/L), Phenylbutazone (400 mg/L), Doxycycline (50 mg/L), Acetylsalicylic Acid (1000 mg/L), Rifampicin (60 mg/L), Acetaminophen (200 mg/L), Ibuprofen (500 mg/L), and Theophyllin (100 mg/L). The labeling states that no interference was found at therapeutic concentrations using common drug panels. Interference was observed with Cefoxitin and Cyanokit. The labeling states that Cyanokit (Hydroxocobalamin) and Cefoxitin at therapeutic concentrations interfere with the test. f. Assay cut-off: Not applicable. 8 2. Comparison studies: a. Method comparison with predicate device: A total of 105 human serum samples with values ranging from 10.1 to 1939 U/L were tested in singlicate with the CK-MB assay on a Roche cobas c 501 analyzer and the predicate device. Four of the 105 samples were spiked with recombinant human CK- MB. The data were evaluated using Passing-Bablok regression analysis. The results are shown below. y =0.977x + 1.12 U/L, r = 0.968 b. Matrix comparison: A matrix comparison study was performed by comparing reference serum samples (in serum tubes) with 31 serum samples (in gel separation tubes) or plasma samples (in 30 K2 EDTA tubes, 31 K3 EDTA tubes, or 31 Li Heparin tubes). Samples ranging from 10.1 to 1956 U/L were tested in singlicate on the cobas c 501 analyzer. Regression analysis was performed using the serum data as the reference. The results of these studies are shown below. Anticoagulant Regression Analysis R Serum vs. Serum Gel Separation y = 0.996x + 0.804 U/L 1.00 Serum vs. Li-heparin y = 1.00x – 0.616 U/L 0.999 Serum vs. K2-EDTA y = 1.00x – 0.717 U/L 0.999 Serum vs. K3-EDTA y = 0.995x - 0.062 U/L 1.00 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 9 5. Expected values/Reference range: For healthy people, according to Klein et al.1 and consensus values2: CK-MB < 25 U/L. The reagents used in the reference interval studies in Klein, et al., are identical to the proposed device. Reference intervals for CK-MB were performed at 6 sites with healthy individuals (202 males and 217 females ranging in age from 20-60 years). Reference intervals were reported as follows: CK-MB (2.5-97.5%) of 8-24 U/L for males and CK- MB (2.5-97.5%) of 6-25 U/L for females. The labeling states: Reference intervals strongly depend on the patient group regarded and the specific clinical situation. Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary, determine its own reference ranges. 1Klein G, Berger A, Bertholf R, et al. Abstract: Multicenter Evaluation of Liquid Reagents for CK, CK-MB and LDH with Determination of Reference Intervals on Hitachi Systems. Clin Chem 2001; 47:Suppl.A30. 2Thomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK162526_s2000_e4000

K162526.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

with addition of antibodies. Stability: The reagent shelf life stability claim is 12 months at 2-8°C. The reagent onboard (in use and refrigerated) stability claim is 8 weeks. The protocols were reviewed and found acceptable. Calibrator: The calibrator used with the CK-MB assay is the previously cleared Roche Diagnostics Calibrator for Automated Systems (k101456). 6 d. Detection limit: Limits of detection studies followed the guidelines in CLSI EP17-A2. The Limit of Blank (LoB) was determined as the 95th percentile of measurements of blank samples. The LoB calculation was performed with one analyte-free sample measured in 10 replicates with 3 reagent lots over 6 runs, 3 days, and on one cobas c 501 analyzer. In total, 60 measurements were obtained per lot. Data analysis is based on determination of the 95th percentile of the 60 measured values. The Limit of Detection (LoD) was defined as the lowest amount of analyte in a sample detected with a 95% probability. For determination of LoD, five human serum samples with low analyte concentrations (approximately up to 4 times the LoB) were run in duplicate with 3 reagent lots over 6 runs, 3 days, and on one cobas c 501 analyzer. In total, 60 measurements were obtained per lot. LoD was determined using the following equation: LoD = LoB + 1.653 × SDtot. The Limit of Quantitation (LoQ) is defined as the lowest analyte concentration that can be quantified with a %CV of no more than 20%. For determination of LoQ, a low level sample set was prepared by diluting 5 human serum samples with an analyte free diluent (0.9% NaCl). The low level sample set was tested in 5 replicates per sample on 5 days, one run per day on one cobas c 501 analyzer. The results of the evaluation of the detection limits for one representative reagent lot and the final claim are in the table below. Reagent Lot 2 (U/L) Claim (U/L) Limit of Blank 0.3 3 Limit of Detection 1.0 3 Limit of Quantitation 1.9 10 e. Analytical specificity: Endogenous interference: The effects of interference by hemoglobin, lipemia (Intralipid), and bilirubin on the CK-MB test system was determined on the cobas c 501 analyzer using pooled human serum samples with 2 CK-MB levels (Level 1: ~18 U/L, Level 2: ~1180 U/L) and spiked with varying levels of interferent. The resulting sample series (10 interferent levels per sample) were tested in triplicate and the mean values were used to calculate % recovery, by comparing the measured concentration to the expected concentration (i.e. CK-MB concentration when no interferent is added). A compound was identified as an interferent if the difference between the spiked test sample and the reference sample was >10%. The results are shown in the table below. 7 Interferent No interference up to: Information in the labeling Conjugated Bilirubin Level 1: 76 I Index Level 2: 76 I Index No significant interference up to an I index of 60 for conjugated and 20 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 60 mg/dL and approximate unconjugated bilirubin concentration: 20 mg/dL). Unconjugated Bilirubin Level 1: 28 I Index Level 2: 67 I Index Lipemia Level 1: 753 L Index Level 2: 632 L Index No significant interference up to an L index of 500. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration. Choose diluted sample treatment for automatic rerun. Hemolysis interferes with the assay. The labeling states; Do not use hemolyzed samples. Exogenous Interference: Two serum sample pools containing 2 levels of CK-MB (Level 1: ~22 U/L, Level 2: ~1065 U/L) were divided into aliquots. The concentration of an unspiked aliquot, used as a reference sample, was determined in triplicate on a cobas c501 analyzer. The other sample aliquots were spiked with the respective amount of drug and their CK-MB concentrations determined in triplicate. The means of the triplicate determinations for spiked samples and the reference were compared. A drug was identified as an interferent if the difference between the spiked test sample and the reference sample was >10%. No interference was observed in the presence of Acetylcysteine (1660 mg/L), Ampicillin-Na (1000 mg/L), Ascorbic acid (300 mg/L), Cyclosporine (5 mg/L), Heparin (5000 U), Levodopa (20 mg/L), Methyldopa +1.5 (20 mg/L), Metronidazole (200 mg/L), Phenylbutazone (400 mg/L), Doxycycline (50 mg/L), Acetylsalicylic Acid (1000 mg/L), Rifampicin (60 mg/L), Acetaminophen (200 mg/L), Ibuprofen (500 mg/L), and Theophyllin (100 mg/L). The labeling states that no interference was found at therapeutic concentrations using common drug panels. Interference was observed with Cefoxitin and Cyanokit. The labeling states that Cyanokit (Hydroxocobalamin) and Cefoxitin at therapeutic concentrations interfere with the test. f. Assay cut-off: Not applicable. 8 2. Comparison studies: a. Method comparison with predicate device: A total of 105 human serum samples with values ranging from 10.1 to 1939 U/L were tested in singlicate with the CK-MB assay on a Roche cobas c 501 analyzer and the predicate device. Four of the 105 samples were spiked with recombinant human CK- MB. The data were evaluated using Passing-Bablok regression analysis. The results are shown below. y =0.977x + 1.12 U/L, r = 0.968 b. Matrix comparison: A matrix comparison study was performed by comparing reference serum samples (in serum tubes) with 31 serum samples (in gel separation tubes) or plasma samples (in 30 K2 EDTA tubes, 31 K3 EDTA tubes, or 31 Li Heparin tubes). Samples ranging from 10.1 to 1956 U/L were tested in singlicate on the cobas c 501 analyzer. Regression analysis was performed using the serum data as the reference. The results of these studies are shown below. Anticoagulant Regression Analysis R Serum vs. Serum Gel Separation y = 0.996x + 0.804 U/L 1.00 Serum vs. Li-heparin y = 1.00x – 0.616 U/L 0.999 Serum vs. K2-EDTA y = 1.00x – 0.717 U/L 0.999 Serum vs. K3-EDTA y = 0.995x - 0.062 U/L 1.00 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 9 5. Expected values/Reference range: For healthy people, according to Klein et al.1 and consensus values2: CK-MB < 25 U/L. The reagents used in the reference interval studies in Klein, et al., are identical to the proposed device. Reference intervals for CK-MB were performed at 6 sites with healthy individuals (202 males and 217 females ranging in age from 20-60 years). Reference intervals were reported as follows: CK-MB (2.5-97.5%) of 8-24 U/L for males and CK- MB (2.5-97.5%) of 6-25 U/L for females. The labeling states: Reference intervals strongly depend on the patient group regarded and the specific clinical situation. Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary, determine its own reference ranges. 1Klein G, Berger A, Bertholf R, et al. Abstract: Multicenter Evaluation of Liquid Reagents for CK, CK-MB and LDH with Determination of Reference Intervals on Hitachi Systems. Clin Chem 2001; 47:Suppl.A30. 2Thomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK160682_s0_e2000

K160682.txt

purpose for submission

New device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Purpose for submission:

idK160682_s0_e2000

K160682.txt

measurand

Glucose in fresh capillary whole blood from the fingertip and palm.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Measurand:

idK160682_s0_e2000

K160682.txt

type of test

Quantitative, Amperometric method, Glucose dehydrogenase (FAD)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Type of test:

idK160682_s0_e2000

K160682.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Classification:

idK160682_s0_e2000

K160682.txt

panel

75, Clinical Chemistry

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Panel:

idK160682_s0_e2000

K160682.txt

intended use

See indications for use below.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Intended use:

idK160682_s0_e2000

K160682.txt

indications for use

The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Indications for use:

idK160682_s0_e2000

K160682.txt

predicate device name

CONTOUR NEXT USB Blood Glucose Meter

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Predicate device name:

idK160682_s0_e2000

K160682.txt

applicant

Ascensia Diabetes Care

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Applicant:

idK160682_s0_e2000

K160682.txt

proprietary and established names

CONTOUR NEXT ONE Blood Glucose Monitoring System

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Proprietary and established names:

idK160682_s0_e2000

K160682.txt

regulation section

21 CFR 862.1345

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160682 B. Purpose for Submission: New device C. Measurand: Glucose in fresh capillary whole blood from the fingertip and palm. D. Type of Test: Quantitative, Amperometric method, Glucose dehydrogenase (FAD) E. Applicant: Ascensia Diabetes Care F. Proprietary and Established Names: CONTOUR NEXT ONE Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 2. Classification: Class II 3. Product code: NBW, Blood glucose test system, over the counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: 75, Clinical Chemistry H. Intended Use: 1. Intended use: See indications for use below. 2. Indications for use: The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only. · Do not use for diagnosis of, or screening of diabetes · Alternative site testing should be done only when glucose is not changing rapidly. · The Contour Next ONE meter is not indicated for neonatal use · The system should not be used to test critically ill patients. · The system should not be used by persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. · Do not calibrate a continuous glucose monitoring device from an AST result. · Do not calculate an insulin dose based on an AST result. · This system has not been tested at altitudes higher than 20,674 feet (6301 meters). 3 4. Special instrument requirements: CONTOUR NEXT ONE Blood glucose meter I. Device Description: The Contour® NEXT One Blood Glucose Monitoring System consists of the Contour Next One blood glucose meter, the Contour Next test strips (sold separately; previously cleared in k111268), two levels of the Contour Next control solutions (sold separately; previously cleared in k151742), lancing device, lancets, clear endcap (sold separately), and user manual. The key feature of the new system is the ability to automatically transfer data to a smart device using Bluetooth communication, allowing users to interact with their blood glucose results with a custom application called Contour® Diabetes App. Additionally the Contour® NEXT One meter includes a revised glucose calculation algorithm to further improve the level of accuracy compared to the Contour NEXT system. J. Substantial Equivalence Information: 1. Predicate device name(s): CONTOUR NEXT USB Blood Glucose Meter 2. Predicate 510(k) number(s): k150942 3. Comparison with predicate: Similarities Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Intended Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm as an aid in monitoring the effectiveness of a diabetes control program Same Test strip Contour Next Test Strips Same Test Strip Chemistry FAD-GDH Same Measuring Range 20-600 mg/dL Same Blood sample volume 0.6µL Same Controls CONTOUR NEXT Control Same Control solution ranges Level 1 and Level 2 Same Automatic calibration Yes Same 4 Differences Item Candidate Device CONTOUR NEXT ONE (k160682) Predicate Device CONTOUR NEXT USB (k150942) Wireless technology Bluetooth Low Energy (BLE) to smart phones and tablets No wireless communication PC connection Micro-USB port USB port Display LCD with 7-segments and icons Graphical OLED with text Battery type CR 2032 Lithium Polymer rechargeable Test memory 800 results 2000 results Sample re-application capability 60-second re-application time 30 second re-application time K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The active ingredients on the Contour® NEXT Test Strips are the enzyme, FAD dependent glucose dehydrogenase (FAD-GDH), and an electron mediator. When a blood sample fills the reaction zone of the test strip, a chemical reaction occurs in which the FAD-GDH enzyme causes electrons to pass from glucose molecules to co-factor and the mediator in the test strip. New software in the Contour® NEXT One meter converts the electrical current measurement into glucose concentration and displays the result on the meter LCD screen. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Within run precision was performed using five venous whole blood samples spiked with glucose to five levels. Three test strip lots and ten meters were used for this study. The samples tested ranged from 40-336mg/dL. Each sample was tested ten times on each of ten meters. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: 5 Glucose level (mg/dL) Lot # Mean (mg/dL) SD (mg/dL) % CV 30-50 1 43.7 0.81 1.85 2 43.7 0.93 2.13 3 43.8 0.96 2.18 Combined 43.7 0.90 2.06 51-110 1 77.7 0.97 1.25 2 77.3 1.36 1.76 3 77.9 1.33 1.71 Combined 77.6 1.23 1.59 111-150 1 129.5 1.86 1.43 2 129.1 1.73 1.34 3 129.2 1.68 1.30 Combined 129.3 1.76 1.36 151-250 1 206.1 3.01 1.46 2 204 3.12 1.53 3 205.8 2.43 1.18 Combined 205.3 2.87 1.40 251-400 1 332.9 3.41 1.02 2 331.4 4.45 1.34 3 330.9 3.86 1.17 Combined 331.7 3.93 1.19 The intermediate precision evaluation was performed with three levels of glucose control solutions using three test strip lots and ten Contour NEXT ONE Glucose meters. Each sample was tested in ten replicates for ten days. The average, SD and CV was calculated for each sample. The combined mean, pooled standard deviation and pooled CV for each glucose concentration were calculated using results from all three reagent lots. The results are summarized below: Control Solution Level Lot # Mean (mg/dL) SD (mg/dL) %CV Low 1 41.8 0.51 1.22 2 42.2 0.64 1.52 3 42.1 0.62 1.46 Combined 42.0 0.59 1.41 Normal 1 123.6 1.50 1.22 2 123.5 1.39 1.12 3 123.7 1.58 1.28 Combined 123.6 1.49 1.21 High 1 361.4 4.16 1.15 2 363.2 6.35 1.75 3 364.5 5.44 1.49 Combined 363.1 5.39 1.48 6 b. Linearity/assay reportable range: The claimed measuring range for this device is 20-600 mg/dL. Linearity was evaluated using twenty four Contour NEXT ONE meters, three lots of test strips and venous whole blood samples adjusted to twelve glucose levels (17, 40, 77, 136, 196, 256, 315, 375, 435, 495, 555 and 615 mg/dL). For each sample, twenty four replicate Contour NEXT ONE readings were obtained with each of three Contour Next lots. The values from the Contour NEXT ONE meters were compared with those obtained from the reference method. The results from regression analysis are summarized below: Lot #1: y=0.967x+0.99; R2 = 0.999 Lot #2: y=1.000x+0.57; R2 = 0.999 Lot #3: y=0.988x+1.49; R2 = 0.999 The results of the study support the sponsor’s claimed glucose measurement range of 20 to 600 mg/dL. The meter will display “LO” when the result is less than 20 mg/dL and “HI” when result is Regulation section:

idK160682_s4000_e6000

K160682.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

levels (40, 120, 350 and 520 mg/dL) were tested using three Contour Next Test Strip lots and 24 meters. Glucose concentrations at each hematocrit level (15, 30, 42, 55 and 65%) for were compared with the reference method (YSI 2300). The resulting % bias relative to YSI demonstrated acceptable performance across the claimed hematocrit range of 15 – 65%. 3) Operating Temperature and Humidity: Operating temperature and humidity conditions were evaluated using 15 meters and 2 test strip lots with venous whole blood samples at four glucose levels (40, 120, 350, and 525 mg/dL). The following temperature and humidity conditions were tested: 5°C/10% RH, 5°C/93%, 25°C/50%, 45°C/10%, 45°C/93%. The results support the sponsor’s claimed operating temperature from 41°F to 113°F (5°C to 45°C) and 10% to 93% Relative Humidity. 4) EMC testing and Electrical Safety Studies: The sponsor provided appropriate documentation certifying that electromagnetic (EMC) and wireless coexistent testing was performed and the Contour NEXT ONE Blood Glucose Monitoring Systems was found to be compliant. 5) Readability Assessment: A Flesch-Kincaid Grade Level assessment was conducted on the CONTOUR Next ONE User Guide and CONTOUR Next One Quick reference guide and the results demonstrated that the labeling was written at lower than 8th grade level. 6) Infection control studies: The device is intended for single patient use only. Disinfection efficacy was performed on the materials comprising the meter demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfecting agents, 12 Clorox® Healthcare Bleach Germicidal Wipes (EPA reg. 67619-12) and Clorox® Healthcare Hydrogen Peroxide Wipes (EPA reg. 67619-25). Robustness studies were performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleaning and disinfection cycles (representing weekly disinfection for 5 years, the expected lifetime of the meter) with Clorox Germicidal Wipes (EPA Registration #67619-12). The subject device labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 7) Customer service is available 8:00 am through midnight Eastern Time, 365 days a year. Toll free phone number is 1-800-348-8100 for Bayer Diabetes Care customer support. 8) This device was cleared after the FDA issued final guidance documents for prescription use blood glucose monitoring systems (BGMS) and over-the-counter use blood glucose monitoring systems (SMBG). However, the recommendations in the guidance documents were not followed for this device since the submission was received prior to the finalization of the guidance documents. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK160682_s4000_e6000

K160682.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

4 glucose levels (40, 120, 350 and 520 mg/dL) were tested using three Contour Next Test Strip lots and 24 meters. Glucose concentrations at each hematocrit level (15, 30, 42, 55 and 65%) for were compared with the reference method (YSI 2300). The resulting % bias relative to YSI demonstrated acceptable performance across the claimed hematocrit range of 15 – 65%. 3) Operating Temperature and Humidity: Operating temperature and humidity conditions were evaluated using 15 meters and 2 test strip lots with venous whole blood samples at four glucose levels (40, 120, 350, and 525 mg/dL). The following temperature and humidity conditions were tested: 5°C/10% RH, 5°C/93%, 25°C/50%, 45°C/10%, 45°C/93%. The results support the sponsor’s claimed operating temperature from 41°F to 113°F (5°C to 45°C) and 10% to 93% Relative Humidity. 4) EMC testing and Electrical Safety Studies: The sponsor provided appropriate documentation certifying that electromagnetic (EMC) and wireless coexistent testing was performed and the Contour NEXT ONE Blood Glucose Monitoring Systems was found to be compliant. 5) Readability Assessment: A Flesch-Kincaid Grade Level assessment was conducted on the CONTOUR Next ONE User Guide and CONTOUR Next One Quick reference guide and the results demonstrated that the labeling was written at lower than 8th grade level. 6) Infection control studies: The device is intended for single patient use only. Disinfection efficacy was performed on the materials comprising the meter demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfecting agents, 12 Clorox® Healthcare Bleach Germicidal Wipes (EPA reg. 67619-12) and Clorox® Healthcare Hydrogen Peroxide Wipes (EPA reg. 67619-25). Robustness studies were performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleaning and disinfection cycles (representing weekly disinfection for 5 years, the expected lifetime of the meter) with Clorox Germicidal Wipes (EPA Registration #67619-12). The subject device labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 7) Customer service is available 8:00 am through midnight Eastern Time, 365 days a year. Toll free phone number is 1-800-348-8100 for Bayer Diabetes Care customer support. 8) This device was cleared after the FDA issued final guidance documents for prescription use blood glucose monitoring systems (BGMS) and over-the-counter use blood glucose monitoring systems (SMBG). However, the recommendations in the guidance documents were not followed for this device since the submission was received prior to the finalization of the guidance documents. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK153683_s0_e2000

K153683.txt

purpose for submission

Clearance of a new device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Purpose for submission:

idK153683_s0_e2000

K153683.txt

measurand

Sperm concentration

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Measurand:

idK153683_s0_e2000

K153683.txt

type of test

Centrifuged packed cell height via density gradient separation

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Type of test:

idK153683_s0_e2000

K153683.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Classification:

idK153683_s0_e2000

K153683.txt

product code

GKZ – Counter, Differential Cell

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Product code:

idK153683_s0_e2000

K153683.txt

panel

Hematology (81)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Panel:

idK153683_s0_e2000

K153683.txt

intended use

The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Intended use:

idK153683_s0_e2000

K153683.txt

predicate device name

SpermCheck™ Fertility

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Predicate device name:

idK153683_s0_e2000

K153683.txt

applicant

Sandstone Diagnostics, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Applicant:

idK153683_s0_e2000

K153683.txt

proprietary and established names

Trak® Male Fertility Testing System

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Proprietary and established names:

idK153683_s0_e2000

K153683.txt

regulation section

21 CFR § 864.5220, Automated differential cell counter

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measurand: Sperm concentration D. Type of Test: Centrifuged packed cell height via density gradient separation E. Applicant: Sandstone Diagnostics, Inc. F. Proprietary and Established Names: Trak® Male Fertility Testing System G. Regulatory Information: 1. Regulation section: 21 CFR § 864.5220, Automated differential cell counter 2. Classification: Class II 3. Product code: GKZ – Counter, Differential Cell 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Not applicable 4. Special instrument requirements: The Trak® Male Fertility Testing System (Trak) includes a small instrument, the Engine. It spins a test Prop to compact sperm cells within an introduced semen sample into a visible column. I. Device Description: The Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Prop), and consumables, including collection cups, control solution, and sample droppers. J. Substantial Equivalence Information: 1. Predicate device name(s): SpermCheck™ Fertility 2. Predicate 510(k) number(s): K100341 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use The Trak® Male Fertility Testing System is intended for semi- quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use. SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use. Test Locale Home Use Same Sample Type Human Semen Same Measurand Sperm Concentration Same Differences Item Device Predicate Test Type Semi-Quantitative Qualitative Test Reporting Visual readout of cell column height Visual line Test Principle Centrifuged packed cell height Chromatographic immunoassay Primary Cut-off Result 15 M/mL (lower reference limit, WHO 5th edition guidelines) 20 M/mL (lower reference limit, WHO 4th edition guidelines) Additional Reference Point 55 M/mL (indication of faster time to pregnancy based on Slama et. al. 2002 study) None Test Control Method External quality control Internal control line K. Standard/Guidance Document Referenced (if applicable): World Health Organization. (2010). WHO laboratory manual for the examination and processing of human semen, 5th Ed. Geneva: WHO Press EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 4 L. Test Principle: Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or “pellet”). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on “top” of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended “above” the medium, substantially separated from the sperm cells and are generally too diffuse to visualize. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A one day precision study was carried out by three operators using three Engine/Prop lot combinations, two replicates per run, and two runs at each time point, for a total of 60 replicates per sperm concentration. Measurements were separated into five separate 4-hour time periods. Seven sperm concentrations were selected that challenged the 15 M/mL and 55 M/mL cut-offs. Sperm concentrations of approximately 13 M/mL, 15 M/mL, 17 M/mL, 18 M/mL, 46 M/mL, 57 M/mL, and 62 M/mL as evaluated by a Computer Aided Semen Analysis (CASA) system were tested by Trak. No significant difference in the performance was found within-run, between-runs, and between-operators/lots. A decrease in results over time period was noted for all of the lower level concentrations reflected by an elevated between-period component of variance. Trak results for a given sample decrease over time due to degradation of the semen sample, especially for lower concentration samples. The instructions for use (Owners Guide) indicate that the test is to be run within 2 hours following sample collection to ensure valid results. The following includes grand averages for each condition, sum for each category, and percent correct calls: 5 ID CASA Result Average ± SD (M/mL) # Trak Results ≤ 15 M/mL # Trak Results > 15 M/mL % Correct 15 – 55 M/mL >55 M/mL 1 13.3 ± 0.9 60 0 0 100 2 15.4 ± 0.9 60 0 0 n/a 3 16.7 ± 0.1 30 30 0 50 4 18.2 ± 0.8 18 42 0 70 5 45.8 ± 2.6 0 60 0 100 6 56.7 ± 3.2 0 26 34 n/a 7 61.9 ± 3.8 0 0 60 100 Quality Control Precision A precision study was conducted to establish the precision of the Trak QC material. Two lots each of two formulations of QC material intended to give Trak results of approximately 17.5 M/mL (Control Solution A) and 7.5 M/mL (Control Solution B) were each tested in duplicate in two separate runs per day over 20 non-consecutive days. Both formulations of the Trak QC material meet acceptance criteria, with 100% of results falling within the expected category. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Track Prop Shelf Life Real time stability testing was performed on three lots of Trak Props. At each time point, 20 Props from each lot were tested with concentrations of approximately 10 M/mL and 20 M/mL and visually evaluated against the 15 M/mL threshold. At each time point, one Prop from each lot was tested on cell-free seminal plasma as a control. All samples were freshly prepared from pooled and diluted semen samples at each time point. In order to validate the freshly composed samples, five replicates from each of the 10 M/mL and 20 M/mL samples were tested on Props assembled within 30 days of the tested time point. Results from Trak Props meet acceptance criteria out to a 6 month time point, and a 3 month expiry date is supported by current stability data. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the Trak Props. Quality Control Shelf Life Real time stability testing was performed on three lots of the “Level A” QC material. At the end of each predetermined time point, 10 replicates of the control were tested 6 on Trak Props and visually evaluated against the 15 M/mL threshold. After initial stability testing at specific time points, previously opened vials of the QC material will be re-capped and re-tested 3 months later to establish 3 month open vial stability. Results from the Trak QC material meet acceptance criteria out to a 2 month time point. Real time stability testing is ongoing. Stability data is being maintained to extend the expiry date of the QC material and establish stability of opened bottles Regulation section:

idK153683_s4000_e6000

K153683.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

when collecting a semen sample. Protective gloves are recommended when performing the test for someone else. Hands should be washed with soap and water before and after handling the semen sample or any component of the test kit. 5. Calibration: Not applicable 11 6. Quality Control: The QC material is based on a suspension of polymer beads with a density range that overlaps with sperm cells. When tested on Trak, the QC material produces results that resemble the result produced with a semen sample. There are two control levels. Control A produces a Trak result in the MODERATE range close to the 15 M/mL cut-off (at approximately 17.5 M/mL). Control B produces a Trak result in the LOW range (at approximately 7.5 M/mL). Control A will be provided as part of the Trak system, while Control B will be available through customer service. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Cleaning Robustness A study was conducted to assess whether the Trak Engine performs adequately after repeated cycles of cleaning and disinfection as would occur during end-use. Trak Props were tested in 10 replicates at each of the four different sperm concentrations intended to challenge the 15 M/mL threshold and 55 M/mL feature: approximately 10 M/mL, 20 M/mL, 45 M/mL and 65 M/mL. One set of Props was tested before cleaning and disinfection, and one set of Props was tested after 50 cycles of cleaning with soap and water and disinfection with Super Sani-Wipes, according to the proposed user instruction. Engine spin rates were checked against specifications before and after cleaning and disinfection. The data support the robustness of the Trak Engine to the intended cleaning and disinfection protocol. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK153683_s4000_e6000

K153683.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

be used when collecting a semen sample. Protective gloves are recommended when performing the test for someone else. Hands should be washed with soap and water before and after handling the semen sample or any component of the test kit. 5. Calibration: Not applicable 11 6. Quality Control: The QC material is based on a suspension of polymer beads with a density range that overlaps with sperm cells. When tested on Trak, the QC material produces results that resemble the result produced with a semen sample. There are two control levels. Control A produces a Trak result in the MODERATE range close to the 15 M/mL cut-off (at approximately 17.5 M/mL). Control B produces a Trak result in the LOW range (at approximately 7.5 M/mL). Control A will be provided as part of the Trak system, while Control B will be available through customer service. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Cleaning Robustness A study was conducted to assess whether the Trak Engine performs adequately after repeated cycles of cleaning and disinfection as would occur during end-use. Trak Props were tested in 10 replicates at each of the four different sperm concentrations intended to challenge the 15 M/mL threshold and 55 M/mL feature: approximately 10 M/mL, 20 M/mL, 45 M/mL and 65 M/mL. One set of Props was tested before cleaning and disinfection, and one set of Props was tested after 50 cycles of cleaning with soap and water and disinfection with Super Sani-Wipes, according to the proposed user instruction. Engine spin rates were checked against specifications before and after cleaning and disinfection. The data support the robustness of the Trak Engine to the intended cleaning and disinfection protocol. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK153278_s0_e2000

K153278.txt

purpose for submission

Modified devices to add compatibility with Android mobile platforms

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k153278 B. Purpose for Submission: Modified devices to add compatibility with Android mobile platforms C. Measurand: Capillary Whole Blood Glucose from the fingertip palm, forearm, upper arm, calf or thigh D. Type of Test: Quantitative, amperometric assay, glucose oxidase E. Applicant: Andon Health Co., Ltd F. Proprietary and Established Names: iHealth Wireless Smart Gluco-Monitoring System (BG5) G. Regulatory Information: Regulation Name Class Product Code Panel 21 § 862.1345 Glucose test system II NBW (75) Chemistry 21 § 862.1345 Glucose Oxidase II CGA (75) Chemistry 21 § 862.2100 Calculator/data processing module for clinical use I JQP (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use, below. 2 2. Indication(s) for use: The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco- Smart App mobile application. The iHealth Wireless Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth Wireless Gluco-Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). 3. Special conditions for use statement(s): · Not for use in critically ill patients · The iHealth system is not intended for use on neonates · The iHealth system is not intended for use on arterial blood, serum, or plasma · The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%), resulting in an inaccurate result: ascorbic acid, uric acid, acetaminophen, dopamine, L-dopa · Do not use haemolysis samples, icterus samples, or high lipemia samples. · Patients undergoing oxygen therapy may show results lower than actual levels. · AST should be done only during steady state times when glucose levels are not changing rapidly. · Do not perform AST if you think your glucose is low, you are unaware that you might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · This device is not for use in people who are severely dehydrated, in people who are severely hypotensive, or people who are in shock, consult your healthcare professional immediately when this happens. · Not for use in individuals who are in a hyperglycemic-hyperosmolar state, with or without ketosis. · Use only fresh capillary whole blood samples. · Very low or very high red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hematocrit level, please consult your healthcare provider. · For over-the-counter use · Do not perform AST if you think your glucose is low, you are unaware that you 3 might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · If you take acetaminophen or acetaminophen containing medications (Tylenol, certain cold and flu remedies, or certain prescription drugs) higher than the recommended levels (>5 mg/dL) then you should know that this medication might affect the reliability of your blood glucose results and you should not use this Blood Glucose Monitoring System. If you are unsure, than ask your doctor. · Certain conditions may cause your blood level of uric acid to rise. These conditions include gout or kidney disease. Uric acid levels in your blood are measured by a laboratory test that your doctor orders. You should know that if your blood level of uric acid is high (≥10 mg/dL) then your blood glucose results may be not reliable. If your doctor tells you that your uric acid level is greater than 10 mg/dL, then do not use this blood glucose monitoring system. If you are unsure, then ask your doctor. · Vitamin C (Ascorbic acid (>2 mg/dL) naturally in your blood or from food or taking Vitamin C supplements might cause inaccurate blood glucose results when using this blood glucose monitoring system. 4. Special instrument requirements: iHealth Wireless Smart Glucose Meter (BG5) I. Device Description: The iHealth Wireless Smart Gluco-Monitoring System (BG5) consists of the iHealth Wireless Smart blood glucose meter (BG5), AGS 1000I Test Strips , sterile lancets, lancing device and the iHealth control solutions. Control solutions provided are for Level I, II, and III. The iHealth BG5 meter uses Bluetooth 3.0 Wireless radio technology. The iHealth BG5 meter can display the test results and the test results can also be transmitted to an Apple and Android based mobile device. iHealth Gluco-Smart App is iOS and Android based software for use with the iHealth BG5 meter. When used with this meter, the iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data. Andon is modifying cleared test systems to add Android mobile device compatibility. The BG5 system has been cleared previously in k150833 with Apple-based hardware and software. The meter firmware has not changed. The system’s AGS 1000I Test Strips are identical to the claimed predicate, k123935. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): iHealth BG5 Wireless Smart Gluco-Monitoring System 2. Predicate 510(k) number(s): k123935 3. Comparison with predicate: Similarities Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) IFU Is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Sample Source Capillary whole blood from fingertip, palm, forearm, upper arm, calf or thigh Same Model BG5 (Bluetooth) Same Enzyme Glucose oxidase Same Measuring range 20 – 600 mg/dL Same Hematocrit range 20-60% Same Connectivity to Meter Bluetooth Same Test Strip Calibration QR code scan Same Dimensions 9 mm × 34.5mm × 19mm Same Mobile App name iHealth Gluco-Smart App Same 5 Differences Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) Mobile App version V2.1 V3.4.3 Compatible OS version iOS 5, 6, 7 iOS 7, 8, 9 Android 4.0, 4.2, 4.4, 5.0 Phone Platform iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 Samsung Galaxy S6 Edge Samsung Galaxy S6 Samsung Galaxy S5 Samsung Galaxy S4 Samsung Galaxy S3 Samsung Galaxy Note3 Samsung Galaxy Note2 HTC One M7 LG Nexus 4 LG Nexus 5 Motorola Nexus 6 Display Connect to Apple platform and LED meter display Connect to Apple, and Android platforms and LED meter display 6 K. Standard/Guidance Document Referenced (if applicable): EN 60601-1-2:2007 – Medical electrical equipment, general requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility L. Test Principle: The iHealth Wireless Smart Gluco-Monitoring System (BG5) measures glucose amperometrically. The reaction of glucose oxidase and an electron mediator in the test strip with glucose in the sample produces an electrical current which is proportional to the amount of glucose Purpose for submission:

idK153278_s0_e2000

K153278.txt

measurand

Capillary Whole Blood Glucose from the fingertip palm, forearm, upper arm, calf or thigh

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k153278 B. Purpose for Submission: Modified devices to add compatibility with Android mobile platforms C. Measurand: Capillary Whole Blood Glucose from the fingertip palm, forearm, upper arm, calf or thigh D. Type of Test: Quantitative, amperometric assay, glucose oxidase E. Applicant: Andon Health Co., Ltd F. Proprietary and Established Names: iHealth Wireless Smart Gluco-Monitoring System (BG5) G. Regulatory Information: Regulation Name Class Product Code Panel 21 § 862.1345 Glucose test system II NBW (75) Chemistry 21 § 862.1345 Glucose Oxidase II CGA (75) Chemistry 21 § 862.2100 Calculator/data processing module for clinical use I JQP (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use, below. 2 2. Indication(s) for use: The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco- Smart App mobile application. The iHealth Wireless Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth Wireless Gluco-Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). 3. Special conditions for use statement(s): · Not for use in critically ill patients · The iHealth system is not intended for use on neonates · The iHealth system is not intended for use on arterial blood, serum, or plasma · The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%), resulting in an inaccurate result: ascorbic acid, uric acid, acetaminophen, dopamine, L-dopa · Do not use haemolysis samples, icterus samples, or high lipemia samples. · Patients undergoing oxygen therapy may show results lower than actual levels. · AST should be done only during steady state times when glucose levels are not changing rapidly. · Do not perform AST if you think your glucose is low, you are unaware that you might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · This device is not for use in people who are severely dehydrated, in people who are severely hypotensive, or people who are in shock, consult your healthcare professional immediately when this happens. · Not for use in individuals who are in a hyperglycemic-hyperosmolar state, with or without ketosis. · Use only fresh capillary whole blood samples. · Very low or very high red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hematocrit level, please consult your healthcare provider. · For over-the-counter use · Do not perform AST if you think your glucose is low, you are unaware that you 3 might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · If you take acetaminophen or acetaminophen containing medications (Tylenol, certain cold and flu remedies, or certain prescription drugs) higher than the recommended levels (>5 mg/dL) then you should know that this medication might affect the reliability of your blood glucose results and you should not use this Blood Glucose Monitoring System. If you are unsure, than ask your doctor. · Certain conditions may cause your blood level of uric acid to rise. These conditions include gout or kidney disease. Uric acid levels in your blood are measured by a laboratory test that your doctor orders. You should know that if your blood level of uric acid is high (≥10 mg/dL) then your blood glucose results may be not reliable. If your doctor tells you that your uric acid level is greater than 10 mg/dL, then do not use this blood glucose monitoring system. If you are unsure, then ask your doctor. · Vitamin C (Ascorbic acid (>2 mg/dL) naturally in your blood or from food or taking Vitamin C supplements might cause inaccurate blood glucose results when using this blood glucose monitoring system. 4. Special instrument requirements: iHealth Wireless Smart Glucose Meter (BG5) I. Device Description: The iHealth Wireless Smart Gluco-Monitoring System (BG5) consists of the iHealth Wireless Smart blood glucose meter (BG5), AGS 1000I Test Strips , sterile lancets, lancing device and the iHealth control solutions. Control solutions provided are for Level I, II, and III. The iHealth BG5 meter uses Bluetooth 3.0 Wireless radio technology. The iHealth BG5 meter can display the test results and the test results can also be transmitted to an Apple and Android based mobile device. iHealth Gluco-Smart App is iOS and Android based software for use with the iHealth BG5 meter. When used with this meter, the iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data. Andon is modifying cleared test systems to add Android mobile device compatibility. The BG5 system has been cleared previously in k150833 with Apple-based hardware and software. The meter firmware has not changed. The system’s AGS 1000I Test Strips are identical to the claimed predicate, k123935. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): iHealth BG5 Wireless Smart Gluco-Monitoring System 2. Predicate 510(k) number(s): k123935 3. Comparison with predicate: Similarities Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) IFU Is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Sample Source Capillary whole blood from fingertip, palm, forearm, upper arm, calf or thigh Same Model BG5 (Bluetooth) Same Enzyme Glucose oxidase Same Measuring range 20 – 600 mg/dL Same Hematocrit range 20-60% Same Connectivity to Meter Bluetooth Same Test Strip Calibration QR code scan Same Dimensions 9 mm × 34.5mm × 19mm Same Mobile App name iHealth Gluco-Smart App Same 5 Differences Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) Mobile App version V2.1 V3.4.3 Compatible OS version iOS 5, 6, 7 iOS 7, 8, 9 Android 4.0, 4.2, 4.4, 5.0 Phone Platform iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 Samsung Galaxy S6 Edge Samsung Galaxy S6 Samsung Galaxy S5 Samsung Galaxy S4 Samsung Galaxy S3 Samsung Galaxy Note3 Samsung Galaxy Note2 HTC One M7 LG Nexus 4 LG Nexus 5 Motorola Nexus 6 Display Connect to Apple platform and LED meter display Connect to Apple, and Android platforms and LED meter display 6 K. Standard/Guidance Document Referenced (if applicable): EN 60601-1-2:2007 – Medical electrical equipment, general requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility L. Test Principle: The iHealth Wireless Smart Gluco-Monitoring System (BG5) measures glucose amperometrically. The reaction of glucose oxidase and an electron mediator in the test strip with glucose in the sample produces an electrical current which is proportional to the amount of glucose Measurand:

idK153278_s0_e2000

K153278.txt

type of test

Quantitative, amperometric assay, glucose oxidase

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k153278 B. Purpose for Submission: Modified devices to add compatibility with Android mobile platforms C. Measurand: Capillary Whole Blood Glucose from the fingertip palm, forearm, upper arm, calf or thigh D. Type of Test: Quantitative, amperometric assay, glucose oxidase E. Applicant: Andon Health Co., Ltd F. Proprietary and Established Names: iHealth Wireless Smart Gluco-Monitoring System (BG5) G. Regulatory Information: Regulation Name Class Product Code Panel 21 § 862.1345 Glucose test system II NBW (75) Chemistry 21 § 862.1345 Glucose Oxidase II CGA (75) Chemistry 21 § 862.2100 Calculator/data processing module for clinical use I JQP (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use, below. 2 2. Indication(s) for use: The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco- Smart App mobile application. The iHealth Wireless Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth Wireless Gluco-Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). 3. Special conditions for use statement(s): · Not for use in critically ill patients · The iHealth system is not intended for use on neonates · The iHealth system is not intended for use on arterial blood, serum, or plasma · The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%), resulting in an inaccurate result: ascorbic acid, uric acid, acetaminophen, dopamine, L-dopa · Do not use haemolysis samples, icterus samples, or high lipemia samples. · Patients undergoing oxygen therapy may show results lower than actual levels. · AST should be done only during steady state times when glucose levels are not changing rapidly. · Do not perform AST if you think your glucose is low, you are unaware that you might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · This device is not for use in people who are severely dehydrated, in people who are severely hypotensive, or people who are in shock, consult your healthcare professional immediately when this happens. · Not for use in individuals who are in a hyperglycemic-hyperosmolar state, with or without ketosis. · Use only fresh capillary whole blood samples. · Very low or very high red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hematocrit level, please consult your healthcare provider. · For over-the-counter use · Do not perform AST if you think your glucose is low, you are unaware that you 3 might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · If you take acetaminophen or acetaminophen containing medications (Tylenol, certain cold and flu remedies, or certain prescription drugs) higher than the recommended levels (>5 mg/dL) then you should know that this medication might affect the reliability of your blood glucose results and you should not use this Blood Glucose Monitoring System. If you are unsure, than ask your doctor. · Certain conditions may cause your blood level of uric acid to rise. These conditions include gout or kidney disease. Uric acid levels in your blood are measured by a laboratory test that your doctor orders. You should know that if your blood level of uric acid is high (≥10 mg/dL) then your blood glucose results may be not reliable. If your doctor tells you that your uric acid level is greater than 10 mg/dL, then do not use this blood glucose monitoring system. If you are unsure, then ask your doctor. · Vitamin C (Ascorbic acid (>2 mg/dL) naturally in your blood or from food or taking Vitamin C supplements might cause inaccurate blood glucose results when using this blood glucose monitoring system. 4. Special instrument requirements: iHealth Wireless Smart Glucose Meter (BG5) I. Device Description: The iHealth Wireless Smart Gluco-Monitoring System (BG5) consists of the iHealth Wireless Smart blood glucose meter (BG5), AGS 1000I Test Strips , sterile lancets, lancing device and the iHealth control solutions. Control solutions provided are for Level I, II, and III. The iHealth BG5 meter uses Bluetooth 3.0 Wireless radio technology. The iHealth BG5 meter can display the test results and the test results can also be transmitted to an Apple and Android based mobile device. iHealth Gluco-Smart App is iOS and Android based software for use with the iHealth BG5 meter. When used with this meter, the iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data. Andon is modifying cleared test systems to add Android mobile device compatibility. The BG5 system has been cleared previously in k150833 with Apple-based hardware and software. The meter firmware has not changed. The system’s AGS 1000I Test Strips are identical to the claimed predicate, k123935. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): iHealth BG5 Wireless Smart Gluco-Monitoring System 2. Predicate 510(k) number(s): k123935 3. Comparison with predicate: Similarities Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) IFU Is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Sample Source Capillary whole blood from fingertip, palm, forearm, upper arm, calf or thigh Same Model BG5 (Bluetooth) Same Enzyme Glucose oxidase Same Measuring range 20 – 600 mg/dL Same Hematocrit range 20-60% Same Connectivity to Meter Bluetooth Same Test Strip Calibration QR code scan Same Dimensions 9 mm × 34.5mm × 19mm Same Mobile App name iHealth Gluco-Smart App Same 5 Differences Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) Mobile App version V2.1 V3.4.3 Compatible OS version iOS 5, 6, 7 iOS 7, 8, 9 Android 4.0, 4.2, 4.4, 5.0 Phone Platform iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 Samsung Galaxy S6 Edge Samsung Galaxy S6 Samsung Galaxy S5 Samsung Galaxy S4 Samsung Galaxy S3 Samsung Galaxy Note3 Samsung Galaxy Note2 HTC One M7 LG Nexus 4 LG Nexus 5 Motorola Nexus 6 Display Connect to Apple platform and LED meter display Connect to Apple, and Android platforms and LED meter display 6 K. Standard/Guidance Document Referenced (if applicable): EN 60601-1-2:2007 – Medical electrical equipment, general requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility L. Test Principle: The iHealth Wireless Smart Gluco-Monitoring System (BG5) measures glucose amperometrically. The reaction of glucose oxidase and an electron mediator in the test strip with glucose in the sample produces an electrical current which is proportional to the amount of glucose Type of test:

idK153278_s0_e2000

K153278.txt

intended use

See indications for use, below.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k153278 B. Purpose for Submission: Modified devices to add compatibility with Android mobile platforms C. Measurand: Capillary Whole Blood Glucose from the fingertip palm, forearm, upper arm, calf or thigh D. Type of Test: Quantitative, amperometric assay, glucose oxidase E. Applicant: Andon Health Co., Ltd F. Proprietary and Established Names: iHealth Wireless Smart Gluco-Monitoring System (BG5) G. Regulatory Information: Regulation Name Class Product Code Panel 21 § 862.1345 Glucose test system II NBW (75) Chemistry 21 § 862.1345 Glucose Oxidase II CGA (75) Chemistry 21 § 862.2100 Calculator/data processing module for clinical use I JQP (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use, below. 2 2. Indication(s) for use: The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco- Smart App mobile application. The iHealth Wireless Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth Wireless Gluco-Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). 3. Special conditions for use statement(s): · Not for use in critically ill patients · The iHealth system is not intended for use on neonates · The iHealth system is not intended for use on arterial blood, serum, or plasma · The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%), resulting in an inaccurate result: ascorbic acid, uric acid, acetaminophen, dopamine, L-dopa · Do not use haemolysis samples, icterus samples, or high lipemia samples. · Patients undergoing oxygen therapy may show results lower than actual levels. · AST should be done only during steady state times when glucose levels are not changing rapidly. · Do not perform AST if you think your glucose is low, you are unaware that you might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · This device is not for use in people who are severely dehydrated, in people who are severely hypotensive, or people who are in shock, consult your healthcare professional immediately when this happens. · Not for use in individuals who are in a hyperglycemic-hyperosmolar state, with or without ketosis. · Use only fresh capillary whole blood samples. · Very low or very high red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hematocrit level, please consult your healthcare provider. · For over-the-counter use · Do not perform AST if you think your glucose is low, you are unaware that you 3 might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · If you take acetaminophen or acetaminophen containing medications (Tylenol, certain cold and flu remedies, or certain prescription drugs) higher than the recommended levels (>5 mg/dL) then you should know that this medication might affect the reliability of your blood glucose results and you should not use this Blood Glucose Monitoring System. If you are unsure, than ask your doctor. · Certain conditions may cause your blood level of uric acid to rise. These conditions include gout or kidney disease. Uric acid levels in your blood are measured by a laboratory test that your doctor orders. You should know that if your blood level of uric acid is high (≥10 mg/dL) then your blood glucose results may be not reliable. If your doctor tells you that your uric acid level is greater than 10 mg/dL, then do not use this blood glucose monitoring system. If you are unsure, then ask your doctor. · Vitamin C (Ascorbic acid (>2 mg/dL) naturally in your blood or from food or taking Vitamin C supplements might cause inaccurate blood glucose results when using this blood glucose monitoring system. 4. Special instrument requirements: iHealth Wireless Smart Glucose Meter (BG5) I. Device Description: The iHealth Wireless Smart Gluco-Monitoring System (BG5) consists of the iHealth Wireless Smart blood glucose meter (BG5), AGS 1000I Test Strips , sterile lancets, lancing device and the iHealth control solutions. Control solutions provided are for Level I, II, and III. The iHealth BG5 meter uses Bluetooth 3.0 Wireless radio technology. The iHealth BG5 meter can display the test results and the test results can also be transmitted to an Apple and Android based mobile device. iHealth Gluco-Smart App is iOS and Android based software for use with the iHealth BG5 meter. When used with this meter, the iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data. Andon is modifying cleared test systems to add Android mobile device compatibility. The BG5 system has been cleared previously in k150833 with Apple-based hardware and software. The meter firmware has not changed. The system’s AGS 1000I Test Strips are identical to the claimed predicate, k123935. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): iHealth BG5 Wireless Smart Gluco-Monitoring System 2. Predicate 510(k) number(s): k123935 3. Comparison with predicate: Similarities Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) IFU Is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Sample Source Capillary whole blood from fingertip, palm, forearm, upper arm, calf or thigh Same Model BG5 (Bluetooth) Same Enzyme Glucose oxidase Same Measuring range 20 – 600 mg/dL Same Hematocrit range 20-60% Same Connectivity to Meter Bluetooth Same Test Strip Calibration QR code scan Same Dimensions 9 mm × 34.5mm × 19mm Same Mobile App name iHealth Gluco-Smart App Same 5 Differences Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) Mobile App version V2.1 V3.4.3 Compatible OS version iOS 5, 6, 7 iOS 7, 8, 9 Android 4.0, 4.2, 4.4, 5.0 Phone Platform iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 Samsung Galaxy S6 Edge Samsung Galaxy S6 Samsung Galaxy S5 Samsung Galaxy S4 Samsung Galaxy S3 Samsung Galaxy Note3 Samsung Galaxy Note2 HTC One M7 LG Nexus 4 LG Nexus 5 Motorola Nexus 6 Display Connect to Apple platform and LED meter display Connect to Apple, and Android platforms and LED meter display 6 K. Standard/Guidance Document Referenced (if applicable): EN 60601-1-2:2007 – Medical electrical equipment, general requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility L. Test Principle: The iHealth Wireless Smart Gluco-Monitoring System (BG5) measures glucose amperometrically. The reaction of glucose oxidase and an electron mediator in the test strip with glucose in the sample produces an electrical current which is proportional to the amount of glucose Intended use:

idK153278_s0_e2000

K153278.txt

predicate device name

iHealth BG5 Wireless Smart Gluco-Monitoring System

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k153278 B. Purpose for Submission: Modified devices to add compatibility with Android mobile platforms C. Measurand: Capillary Whole Blood Glucose from the fingertip palm, forearm, upper arm, calf or thigh D. Type of Test: Quantitative, amperometric assay, glucose oxidase E. Applicant: Andon Health Co., Ltd F. Proprietary and Established Names: iHealth Wireless Smart Gluco-Monitoring System (BG5) G. Regulatory Information: Regulation Name Class Product Code Panel 21 § 862.1345 Glucose test system II NBW (75) Chemistry 21 § 862.1345 Glucose Oxidase II CGA (75) Chemistry 21 § 862.2100 Calculator/data processing module for clinical use I JQP (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use, below. 2 2. Indication(s) for use: The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco- Smart App mobile application. The iHealth Wireless Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth Wireless Gluco-Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). 3. Special conditions for use statement(s): · Not for use in critically ill patients · The iHealth system is not intended for use on neonates · The iHealth system is not intended for use on arterial blood, serum, or plasma · The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%), resulting in an inaccurate result: ascorbic acid, uric acid, acetaminophen, dopamine, L-dopa · Do not use haemolysis samples, icterus samples, or high lipemia samples. · Patients undergoing oxygen therapy may show results lower than actual levels. · AST should be done only during steady state times when glucose levels are not changing rapidly. · Do not perform AST if you think your glucose is low, you are unaware that you might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · This device is not for use in people who are severely dehydrated, in people who are severely hypotensive, or people who are in shock, consult your healthcare professional immediately when this happens. · Not for use in individuals who are in a hyperglycemic-hyperosmolar state, with or without ketosis. · Use only fresh capillary whole blood samples. · Very low or very high red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hematocrit level, please consult your healthcare provider. · For over-the-counter use · Do not perform AST if you think your glucose is low, you are unaware that you 3 might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · If you take acetaminophen or acetaminophen containing medications (Tylenol, certain cold and flu remedies, or certain prescription drugs) higher than the recommended levels (>5 mg/dL) then you should know that this medication might affect the reliability of your blood glucose results and you should not use this Blood Glucose Monitoring System. If you are unsure, than ask your doctor. · Certain conditions may cause your blood level of uric acid to rise. These conditions include gout or kidney disease. Uric acid levels in your blood are measured by a laboratory test that your doctor orders. You should know that if your blood level of uric acid is high (≥10 mg/dL) then your blood glucose results may be not reliable. If your doctor tells you that your uric acid level is greater than 10 mg/dL, then do not use this blood glucose monitoring system. If you are unsure, then ask your doctor. · Vitamin C (Ascorbic acid (>2 mg/dL) naturally in your blood or from food or taking Vitamin C supplements might cause inaccurate blood glucose results when using this blood glucose monitoring system. 4. Special instrument requirements: iHealth Wireless Smart Glucose Meter (BG5) I. Device Description: The iHealth Wireless Smart Gluco-Monitoring System (BG5) consists of the iHealth Wireless Smart blood glucose meter (BG5), AGS 1000I Test Strips , sterile lancets, lancing device and the iHealth control solutions. Control solutions provided are for Level I, II, and III. The iHealth BG5 meter uses Bluetooth 3.0 Wireless radio technology. The iHealth BG5 meter can display the test results and the test results can also be transmitted to an Apple and Android based mobile device. iHealth Gluco-Smart App is iOS and Android based software for use with the iHealth BG5 meter. When used with this meter, the iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data. Andon is modifying cleared test systems to add Android mobile device compatibility. The BG5 system has been cleared previously in k150833 with Apple-based hardware and software. The meter firmware has not changed. The system’s AGS 1000I Test Strips are identical to the claimed predicate, k123935. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): iHealth BG5 Wireless Smart Gluco-Monitoring System 2. Predicate 510(k) number(s): k123935 3. Comparison with predicate: Similarities Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) IFU Is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Sample Source Capillary whole blood from fingertip, palm, forearm, upper arm, calf or thigh Same Model BG5 (Bluetooth) Same Enzyme Glucose oxidase Same Measuring range 20 – 600 mg/dL Same Hematocrit range 20-60% Same Connectivity to Meter Bluetooth Same Test Strip Calibration QR code scan Same Dimensions 9 mm × 34.5mm × 19mm Same Mobile App name iHealth Gluco-Smart App Same 5 Differences Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) Mobile App version V2.1 V3.4.3 Compatible OS version iOS 5, 6, 7 iOS 7, 8, 9 Android 4.0, 4.2, 4.4, 5.0 Phone Platform iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 Samsung Galaxy S6 Edge Samsung Galaxy S6 Samsung Galaxy S5 Samsung Galaxy S4 Samsung Galaxy S3 Samsung Galaxy Note3 Samsung Galaxy Note2 HTC One M7 LG Nexus 4 LG Nexus 5 Motorola Nexus 6 Display Connect to Apple platform and LED meter display Connect to Apple, and Android platforms and LED meter display 6 K. Standard/Guidance Document Referenced (if applicable): EN 60601-1-2:2007 – Medical electrical equipment, general requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility L. Test Principle: The iHealth Wireless Smart Gluco-Monitoring System (BG5) measures glucose amperometrically. The reaction of glucose oxidase and an electron mediator in the test strip with glucose in the sample produces an electrical current which is proportional to the amount of glucose Predicate device name:

idK153278_s0_e2000

K153278.txt

applicant

Andon Health Co., Ltd

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k153278 B. Purpose for Submission: Modified devices to add compatibility with Android mobile platforms C. Measurand: Capillary Whole Blood Glucose from the fingertip palm, forearm, upper arm, calf or thigh D. Type of Test: Quantitative, amperometric assay, glucose oxidase E. Applicant: Andon Health Co., Ltd F. Proprietary and Established Names: iHealth Wireless Smart Gluco-Monitoring System (BG5) G. Regulatory Information: Regulation Name Class Product Code Panel 21 § 862.1345 Glucose test system II NBW (75) Chemistry 21 § 862.1345 Glucose Oxidase II CGA (75) Chemistry 21 § 862.2100 Calculator/data processing module for clinical use I JQP (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use, below. 2 2. Indication(s) for use: The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco- Smart App mobile application. The iHealth Wireless Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth Wireless Gluco-Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). 3. Special conditions for use statement(s): · Not for use in critically ill patients · The iHealth system is not intended for use on neonates · The iHealth system is not intended for use on arterial blood, serum, or plasma · The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%), resulting in an inaccurate result: ascorbic acid, uric acid, acetaminophen, dopamine, L-dopa · Do not use haemolysis samples, icterus samples, or high lipemia samples. · Patients undergoing oxygen therapy may show results lower than actual levels. · AST should be done only during steady state times when glucose levels are not changing rapidly. · Do not perform AST if you think your glucose is low, you are unaware that you might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · This device is not for use in people who are severely dehydrated, in people who are severely hypotensive, or people who are in shock, consult your healthcare professional immediately when this happens. · Not for use in individuals who are in a hyperglycemic-hyperosmolar state, with or without ketosis. · Use only fresh capillary whole blood samples. · Very low or very high red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hematocrit level, please consult your healthcare provider. · For over-the-counter use · Do not perform AST if you think your glucose is low, you are unaware that you 3 might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · If you take acetaminophen or acetaminophen containing medications (Tylenol, certain cold and flu remedies, or certain prescription drugs) higher than the recommended levels (>5 mg/dL) then you should know that this medication might affect the reliability of your blood glucose results and you should not use this Blood Glucose Monitoring System. If you are unsure, than ask your doctor. · Certain conditions may cause your blood level of uric acid to rise. These conditions include gout or kidney disease. Uric acid levels in your blood are measured by a laboratory test that your doctor orders. You should know that if your blood level of uric acid is high (≥10 mg/dL) then your blood glucose results may be not reliable. If your doctor tells you that your uric acid level is greater than 10 mg/dL, then do not use this blood glucose monitoring system. If you are unsure, then ask your doctor. · Vitamin C (Ascorbic acid (>2 mg/dL) naturally in your blood or from food or taking Vitamin C supplements might cause inaccurate blood glucose results when using this blood glucose monitoring system. 4. Special instrument requirements: iHealth Wireless Smart Glucose Meter (BG5) I. Device Description: The iHealth Wireless Smart Gluco-Monitoring System (BG5) consists of the iHealth Wireless Smart blood glucose meter (BG5), AGS 1000I Test Strips , sterile lancets, lancing device and the iHealth control solutions. Control solutions provided are for Level I, II, and III. The iHealth BG5 meter uses Bluetooth 3.0 Wireless radio technology. The iHealth BG5 meter can display the test results and the test results can also be transmitted to an Apple and Android based mobile device. iHealth Gluco-Smart App is iOS and Android based software for use with the iHealth BG5 meter. When used with this meter, the iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data. Andon is modifying cleared test systems to add Android mobile device compatibility. The BG5 system has been cleared previously in k150833 with Apple-based hardware and software. The meter firmware has not changed. The system’s AGS 1000I Test Strips are identical to the claimed predicate, k123935. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): iHealth BG5 Wireless Smart Gluco-Monitoring System 2. Predicate 510(k) number(s): k123935 3. Comparison with predicate: Similarities Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) IFU Is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Sample Source Capillary whole blood from fingertip, palm, forearm, upper arm, calf or thigh Same Model BG5 (Bluetooth) Same Enzyme Glucose oxidase Same Measuring range 20 – 600 mg/dL Same Hematocrit range 20-60% Same Connectivity to Meter Bluetooth Same Test Strip Calibration QR code scan Same Dimensions 9 mm × 34.5mm × 19mm Same Mobile App name iHealth Gluco-Smart App Same 5 Differences Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) Mobile App version V2.1 V3.4.3 Compatible OS version iOS 5, 6, 7 iOS 7, 8, 9 Android 4.0, 4.2, 4.4, 5.0 Phone Platform iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 Samsung Galaxy S6 Edge Samsung Galaxy S6 Samsung Galaxy S5 Samsung Galaxy S4 Samsung Galaxy S3 Samsung Galaxy Note3 Samsung Galaxy Note2 HTC One M7 LG Nexus 4 LG Nexus 5 Motorola Nexus 6 Display Connect to Apple platform and LED meter display Connect to Apple, and Android platforms and LED meter display 6 K. Standard/Guidance Document Referenced (if applicable): EN 60601-1-2:2007 – Medical electrical equipment, general requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility L. Test Principle: The iHealth Wireless Smart Gluco-Monitoring System (BG5) measures glucose amperometrically. The reaction of glucose oxidase and an electron mediator in the test strip with glucose in the sample produces an electrical current which is proportional to the amount of glucose Applicant:

idK153278_s0_e2000

K153278.txt

proprietary and established names

iHealth Wireless Smart Gluco-Monitoring System (BG5)

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k153278 B. Purpose for Submission: Modified devices to add compatibility with Android mobile platforms C. Measurand: Capillary Whole Blood Glucose from the fingertip palm, forearm, upper arm, calf or thigh D. Type of Test: Quantitative, amperometric assay, glucose oxidase E. Applicant: Andon Health Co., Ltd F. Proprietary and Established Names: iHealth Wireless Smart Gluco-Monitoring System (BG5) G. Regulatory Information: Regulation Name Class Product Code Panel 21 § 862.1345 Glucose test system II NBW (75) Chemistry 21 § 862.1345 Glucose Oxidase II CGA (75) Chemistry 21 § 862.2100 Calculator/data processing module for clinical use I JQP (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use, below. 2 2. Indication(s) for use: The iHealth Wireless Gluco-Monitoring System consists of the iHealth Wireless Glucose meter (BG5), iHealth Blood Glucose Test Strips (AGS-1000I), and the iHealth Gluco- Smart App mobile application. The iHealth Wireless Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Gluco-Monitoring System is intended to be used by a single person and should not be shared. The iHealth Wireless Gluco-Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). 3. Special conditions for use statement(s): · Not for use in critically ill patients · The iHealth system is not intended for use on neonates · The iHealth system is not intended for use on arterial blood, serum, or plasma · The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%), resulting in an inaccurate result: ascorbic acid, uric acid, acetaminophen, dopamine, L-dopa · Do not use haemolysis samples, icterus samples, or high lipemia samples. · Patients undergoing oxygen therapy may show results lower than actual levels. · AST should be done only during steady state times when glucose levels are not changing rapidly. · Do not perform AST if you think your glucose is low, you are unaware that you might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · This device is not for use in people who are severely dehydrated, in people who are severely hypotensive, or people who are in shock, consult your healthcare professional immediately when this happens. · Not for use in individuals who are in a hyperglycemic-hyperosmolar state, with or without ketosis. · Use only fresh capillary whole blood samples. · Very low or very high red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hematocrit level, please consult your healthcare provider. · For over-the-counter use · Do not perform AST if you think your glucose is low, you are unaware that you 3 might have hypoglycemia, you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose results fluctuate often · Do not use AST results to calibrate a continuous glucose monitor (CGM) · Do not use AST results for insulin dosing calculations · If you take acetaminophen or acetaminophen containing medications (Tylenol, certain cold and flu remedies, or certain prescription drugs) higher than the recommended levels (>5 mg/dL) then you should know that this medication might affect the reliability of your blood glucose results and you should not use this Blood Glucose Monitoring System. If you are unsure, than ask your doctor. · Certain conditions may cause your blood level of uric acid to rise. These conditions include gout or kidney disease. Uric acid levels in your blood are measured by a laboratory test that your doctor orders. You should know that if your blood level of uric acid is high (≥10 mg/dL) then your blood glucose results may be not reliable. If your doctor tells you that your uric acid level is greater than 10 mg/dL, then do not use this blood glucose monitoring system. If you are unsure, then ask your doctor. · Vitamin C (Ascorbic acid (>2 mg/dL) naturally in your blood or from food or taking Vitamin C supplements might cause inaccurate blood glucose results when using this blood glucose monitoring system. 4. Special instrument requirements: iHealth Wireless Smart Glucose Meter (BG5) I. Device Description: The iHealth Wireless Smart Gluco-Monitoring System (BG5) consists of the iHealth Wireless Smart blood glucose meter (BG5), AGS 1000I Test Strips , sterile lancets, lancing device and the iHealth control solutions. Control solutions provided are for Level I, II, and III. The iHealth BG5 meter uses Bluetooth 3.0 Wireless radio technology. The iHealth BG5 meter can display the test results and the test results can also be transmitted to an Apple and Android based mobile device. iHealth Gluco-Smart App is iOS and Android based software for use with the iHealth BG5 meter. When used with this meter, the iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data. Andon is modifying cleared test systems to add Android mobile device compatibility. The BG5 system has been cleared previously in k150833 with Apple-based hardware and software. The meter firmware has not changed. The system’s AGS 1000I Test Strips are identical to the claimed predicate, k123935. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): iHealth BG5 Wireless Smart Gluco-Monitoring System 2. Predicate 510(k) number(s): k123935 3. Comparison with predicate: Similarities Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) IFU Is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Sample Source Capillary whole blood from fingertip, palm, forearm, upper arm, calf or thigh Same Model BG5 (Bluetooth) Same Enzyme Glucose oxidase Same Measuring range 20 – 600 mg/dL Same Hematocrit range 20-60% Same Connectivity to Meter Bluetooth Same Test Strip Calibration QR code scan Same Dimensions 9 mm × 34.5mm × 19mm Same Mobile App name iHealth Gluco-Smart App Same 5 Differences Item Predicate Device iHealth BG5 Wireless Smart Gluco-Monitoring System (k123935) Candidate Device iHealth Wireless Smart Gluco- Monitoring System (BG5) (k153278) Mobile App version V2.1 V3.4.3 Compatible OS version iOS 5, 6, 7 iOS 7, 8, 9 Android 4.0, 4.2, 4.4, 5.0 Phone Platform iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 iPhone 5s iPhone 5c iPhone 5 iPhone 4S iPhone 4 iPhone 3GS iPod touch (4th generation) iPod touch (5th generation) iPad2 iPad3 iPad4 iPad Mini iPad Mini 2 iPad Air iPad Air 2 Samsung Galaxy S6 Edge Samsung Galaxy S6 Samsung Galaxy S5 Samsung Galaxy S4 Samsung Galaxy S3 Samsung Galaxy Note3 Samsung Galaxy Note2 HTC One M7 LG Nexus 4 LG Nexus 5 Motorola Nexus 6 Display Connect to Apple platform and LED meter display Connect to Apple, and Android platforms and LED meter display 6 K. Standard/Guidance Document Referenced (if applicable): EN 60601-1-2:2007 – Medical electrical equipment, general requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility L. Test Principle: The iHealth Wireless Smart Gluco-Monitoring System (BG5) measures glucose amperometrically. The reaction of glucose oxidase and an electron mediator in the test strip with glucose in the sample produces an electrical current which is proportional to the amount of glucose Proprietary and established names:

idK153278_s4000_e6000

K153278.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. 12 R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK151046_s0_e2000

K151046.txt

purpose for submission

To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Purpose for submission:

idK151046_s0_e2000

K151046.txt

measurand

Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2).

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Measurand:

idK151046_s0_e2000

K151046.txt

type of test

Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Type of test:

idK151046_s0_e2000

K151046.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Classification:

idK151046_s0_e2000

K151046.txt

product code

PGI

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Product code:

idK151046_s0_e2000

K151046.txt

panel

Microbiology (83)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Panel:

idK151046_s0_e2000

K151046.txt

indications for use

Same as Intended Use.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Indications for use:

idK151046_s0_e2000

K151046.txt

predicate device name

Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation)

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Predicate device name:

idK151046_s0_e2000

K151046.txt

applicant

Meridian Bioscience, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Applicant:

idK151046_s0_e2000

K151046.txt

regulation section

21 CFR 866.3309

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151046 B. Purpose for Submission: To obtain substantial equivalence determination for the illumigene® HSV 1&2 DNA Amplification Assay. C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2). D. Type of Test: Qualitative in vitro diagnostic device for the direct detection and differentiation of HSV-1 and HSV-2 DNA in cutaneous and mucocutaneous lesion specimens from symptomatic patients suspected of Herpetic infections. E. Applicant: Meridian Bioscience, Inc. F. Proprietary and Established Names: illumigene® HSV 1&2 DNA Amplification Assay illumigene® HSV 1&2 External Controls G. Regulatory Information: 1. Regulation section: 21 CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: Testing is performed on the illumipro-10™ Automated Isothermal Amplification and Detection System from Meridian Bioscience, Inc. I. Device Description: The illumigene Molecular Diagnostic Test System is comprised of the illumigene HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Control Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. The illumigene HSV 1&2 kit includes the illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 3 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and 50 µL transfer pipettes. The specimen is added directly to the single-use SMP PREP III, which contains buffer and formalin-treated E. coli harboring S. aureus DNA. The S. aureus DNA serves as internal control DNA. A sample processed through the SMP PREP III is then heat-treated to make target and internal control DNA available for amplification. The heat-treated sample is added to each illumigene HSV 1 and illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumigene HSV Test Device is a two-chambered device containing lyophilized amplification reagents (DNA polymerase, deoxynucleotide triphosphates) and either HSV-1 or 2-specific primers in the TEST chamber and S. aureus-specific primers in the CONTROL chamber. The illumigene HSV 2 Test Device is visually identified by an orange band on the Test Device closure tab. The illumipro-10 heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target and internal control DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair sequence (bp) of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, Si) and at the assay Run End (Signal final, Sf). The illumipro-10 calculates the change in light transmission between Run End and Run Start (Sf:Si) and compares the ratio to a fixed cut-off value for disposition of results. Fixed cut-off values for the CONTROL chamber are used to determine validity. Fixed cut-off values for the TEST chamber are used to report sample results. CONTROL chamber Sf:Si ratios less than 90% are considered valid and allow for reporting of TEST chamber results. CONTROL chamber Sf:Si ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as ‘INVALID’. TEST chamber Sf:Si ratios less than 82% are reported as ‘POSITIVE’; TEST chamber Sf:Si ratios greater than or equal to 82% are reported as ‘NEGATIVE’. Numerical values are not reported. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to assist the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Lyra™ Direct HSV 1 + 2/VZV assay (Quidel Corporation) 2. Predicate 510(k) number(s): K133448 3. Comparison with predicate: Similarities DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Intended Use Qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Assay Results Qualitative Qualitative Indications for Use Professional Use Professional Use DNA Detected Herpes simplex virus type 1 Herpes simplex virus type 2 Herpes simplex virus type 1 Herpes simplex virus type 2 Varicella-zoster virus Typing of HSV-1 andHSV-2? Yes Yes Specimen Types Male and female cutaneous and mucocutaneous lesion swab specimens Male and female cutaneous and mucocutaneous lesion swab specimens Method DNA Amplification DNA Amplification Detection Instrument Instrument 5 Differences DEVICE illumigene® HSV 1&2 DNA Amplification Assay K151046 PREDICATE Quidel Lyra™ Direct HSV 1 + 2/VZV Assay K133448 Amplification Methodology Loop-Mediated Isothermal Amplification (LAMP) Multiplex Real-Time PCR Detection Methodology Turbidity Target-specific fluorescent-labeled hybridization probes Reagents/ Components The illumigene HSV 1&2 DNA Amplification Assay Kit contains illumigene Sample Preparation Apparatus III, illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and Transfer Pipettes. The Lyra™ Direct HSV 1 + 2/VZV Assay kit consists of: - Rehydration Solution - Process Buffer Part M5050 (contains the PRC) - Lyra™ Direct HSV 1 + 2/VZV Master Mix Part M5012 - Lyophilized Contents: o DNA polymerase enzyme o Primers and probes o dNTPs o Stabil Regulation section:

idK151046_s10000_e12000

K151046.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

were generated by the illumigene HSV 1&2 DNA Amplification Assay. For HSV-1 mucocutaneous specimens, there were 710 valid results with the ELVIS method with six initially invalid results by the illumigene HSV 1&2 DNA Amplification Assay. All initially invalid results were resolved by repeat testing as per the Package Insert and included in the performance calculation. For HSV-2 cutaneous specimens, there were 306 valid results with the ELVIS method with one initially invalid result by the illumigene HSV 1&2 DNA Amplification Assay. The initially invalid result was resolved by repeat testing and included in the performance calculation. For HSV-2 mucocutaneous specimens, there were 849 valid results with the ELVIS method with one originally invalid result by the illumigene HSV 1&2 DNA Amplification Assay. The initially invalid results was resolved and included in the performance calculation. The performance of the illumigene HSV 1&2 DNA Amplification Assay against the ELVIS reference method is presented in Table 6 below: 20 Table 6. Clinical Performance Combined Sites: HSV-1 Cutaneous (N=264) Reference Method illumi- gene Performance Pos Neg Total INVc 95% CI illumigene HSV 1&2 Pos 48 6a 54 0 (0) Sens 48/51 94.1% 84.1-98.0% Neg 3b 207 210 0 (0) Spec 207/213 97.2% 94.0-98.7% Total 51 213 264 0 (0) a 6/6 specimens identified as HSV-1 positive by an alternative, FDA-cleared molecular assay. b 1/3 specimens identified as HSV-1 negative by an alternative, FDA-cleared molecular assay. c Initial invalid results are reported within the parentheses. The final number of invalid specimens remaining after repeat testing is shown before the parenthesis. Combined Sites: HSV-1 Mucocutaneous (N=710) Reference Method illumi- gene Performance Pos Neg Total INVd 95% CI illumigene HSV 1&2 Pos 152 28b 180 0 (1) Sens 152/160 95.0% 90.5-97.5% Neg 8c 522 530 0 (5) Spec 522/550 94.9% 92.7-96.5% Total 160 550 710 0 (6)a a There were six initial INV specimens by illumigene. Five repeated as illumigene negative (ELVIS negative); one repeated as illumigene HSV 1 positive (ELVIS HSV 1 positive). b 19/28 specimens identified as HSV-1 positive by an alternative, FDA-cleared molecular assay; 3 specimens could not be tested. c 7/8 specimens were identified as HSV-1 negative by an alternative, FDA-cleared molecular assay; 1 sample could not be tested. d Initial invalid results are reported within the parentheses. The final number of invalid specimens remaining after repeat testing is shown before the parenthesis. Combined Sites: HSV-2 Cutaneous (N=306) Reference Method illumi- gene Performance Pos Neg Total INVc 95% CI illumigene HSV 1&2 Pos 42 13b 55 0 (0) Sens 42/42 100% 91.6-100.0% Neg 0 251 251 0 (1) Spec 251/264 95.1% 91.8-97.1% Total 42 264 306 0 (1)a a There was one initial INV sample by illumigene. The sample repeated as illumigene negative (ELVIS negative). b 8/13 specimens were identified as HSV-2 positive by an alternative, FDA-cleared molecular assay; 1 sample could not be tested. c Initial invalid results are reported within the parentheses. The final number of invalid specimens remaining after repeat testing is shown before the parenthesis. 21 Combined Sites: HSV-2 Mucocutaneous (N=849) Reference Method illumi- gene Performance Pos Neg Total INVd 95% CI illumigene HSV 1&2 Pos 137 31b 168 0 (0) Sens 137/139 98.6% 94.9-99.6% Neg 2c 679 681 0 (1) Spec 679/710 95.6% 93.9-96.9% Total 139 710 849 0 (1)a a There was one initial INV sample by illumigene. The sample repeated illumigene negative (ELVIS negative). b 24/31 specimens were identified as HSV-2 positive by an alternative, FDA-cleared molecular assay; 4 specimens could not be tested. c 1/2 specimens were identified as HSV-2 negative by an alternative, FDA-cleared molecular assay. d Initial invalid results are reported within the parentheses. The final number of invalid specimens remaining after repeat testing is shown before the parenthesis. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: The observed expected values in the clinical study were calculated using all eligible cutaneous and mucocutaneous lesion specimens submitted for HSV testing that gave valid illumigene HSV 1&2 assay results. Three HSV-1 and two HSV-2 specimens producing invalid illumigene results that could not be resolved were excluded from the 1158 total eligible sample population. Therefore, the total number of tested specimens that were included in the prevalence calculation were N=1155 for HSV-1 and N=1156 for HSV-2. The overall incidence of HSV infection by the illumigene HSV 1&2 assay during the clinical study was 20.5% (237/1155) for HSV-1 and 19.4% (224/1156) for HSV-2. The prevalence of HSV-1 and HSV-2 with the illumigene HSV 1&2 DNA Amplification Assay was calculated for the combined sites based on the specific source of specimen and the age of the patient. Of the eligible specimens, 306 were from cutaneous lesions. 849 were mucocutaneous specimens tested for HSV-1 and 850 were mucocutaneous specimens tested for HSV-2. There were three specimens tested for HSV-1 and two tested for HSV-2 mucocutaneous from patients with unknown age. The study population included specimens from pediatric, adult, and geriatric patients, with ages ranging from 1 day to 89 years. The prevalence of HSV-1 and HSV-2 by the illumigene HSV 1&2 assay by anatomical location and patient age is provided in the tables below. 22 Prevalence by Anatomical Location (All Sites) – Cutaneous Location HSV-1 N=306 HSV-2 N=306 Total # Total Positive Prevalence Total # Total Positive Prevalence Genital - Penis 92 7 7.6% 92 28 30.4% Skin Lesion 214 47 22.0% 214 27 12.6% Prevalence by Anatomical Location (All Sites) – Mucocutaneous Location HSV-1 N=849 HSV-2 N=850 Total # Total Positive Prevalence Total # Total Positive Prevalence Anorectal 47 (1*) 7 14.9% 46 (2*) 9 19.6% Genital-Vaginal/Cervical 624 (2*) 112 17.9% 626 158 25.2% Nasal 18 9 50.0% 18 0 0.0 % Ocular 20 0 0.0% 20 0 0.0 % Oral Lesion 135 54 40.0% 135 2 1.5 % Urethral 5 1 20.0% 5 0 0.0 % *Number of specimens producing invalid illumigene result, which could not be resolved and therefore, were excluded from the analysis. Prevalence by Age (All Sites) – Cutaneous Age HSV-1 N=306 HSV-2 N=306 Total # Total Positive Prevalence Total # Total Positive Prevalence ≤ 5 years 38 12 31.6% 38 1 2.6% 6 to 11 years 14 7 50.0% 14 1 7.1% 12 to 21 years 51 14 27.5% 51 4 7.8% 22 to 59 years 166 18 10.8% 166 36 21.7% ≥60 years 37 3 8.1% 37 13 35.1% Not Provided 0 0 0.0% 0 0 0.0% %% Prevalence by Age (All Sites) – Mucocutaneous Age HSV-1 N=849 HSV-2 N=850 Total # Total Positive Prevalence Total # Total Positive Prevalence ≤ 5 years 47 8 17.0% 47 0 0.0% 6 to 11 years 12 0 0.0% 12 0 0.0% 12 to 21 years 174 (1*) 46 26.4% 175 42 24.0% 22 to 59 years 550 (1*) 111 20.2% 551 116 21.1% ≥60 years 63 (1*) 18 28.6% 63 (1*) 11 17.5% Not Provided 3 0 0.0% 2 (1*) 0 0.0% *Number of specimens producing invalid illumigene result, which could not be resolved and therefore, were excluded from the analysis. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. 23 O. Conclusion: The submitted information in this premarket notification is complete and supports Proposed labeling:

idK181324_s0_e2000

K181324.txt

purpose for submission

To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K181324 B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus C. Measurands: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ. D. Type of Test: Qualitative and quantitative nucleic acid amplification assay E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray Pneumonia Panel plus G. Regulatory Information: 1. Regulation section: 21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic acid detection system 2. Classification: Class II (Special Controls) 3. Product code: PZF 2 4. Panel: 83-Microbiology H. Indications for use: 1. Indications for use(s): The FilmArray Pneumonia Panel plus is a multiplexed nucleic acid test intended for use with FilmArray, FilmArray 2.0, or FilmArray Torch systems for the simultaneous detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria. Testing with FilmArray Pneumonia Panel plus should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected MERS-CoV specimens. This includes: clinical signs and symptoms associated with MERS-CoV infection, contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiological links for which MERS- CoV testing may be indicated. The following bacteria are reported semi-qualitatively with bins representing approximately 104, 105, 106, or ≥107 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104, 105, 106, or ≥107 copies/mL Acinetobacter calcoaceticus- baumannii complex Klebsiella oxytoca Serratia marcescens Enterobacter cloacae complex Klebsiella pneumoniae group Staphylococcus aureus Escherichia coli Moraxella catarrhalis Streptococcus agalactiae Haemophilus influenzae Proteus spp. Streptococcus pneumoniae Klebsiella aerogenes Pseudomonas aeruginosa Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: 3 Atypical Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae Viruses Middle East Resipiratory Syndrome Coronavirus Adenovirus Human Rhinovirus/Enterovirus Parainfluenza Virus Coronavirus Influenza A Respiratory Syncytial Virus Human Metapneumovirus Influenza B Antimicrobial Resistance Genes CTX-M NDM mecA/C and MREJ IMP OXA-48-like KPC VIM The detection and identification of specific viral and bacterial nucleic acids from MERS- CoV and other respiratory pathogens, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals meeting MERS-CoV clinical and/or epidemiological criteria aids in the differential diagnosis of MERS-CoV infection, if used in conjunction with other clinical and epidemiological information in accordance with the guidelines provided by the appropriate public health authorities. FilmArray Pneumonia Panel plus MERS-CoV positive results are for the presumptive identification of MERS-CoV. The definitive identification of MERS-CoV requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. The diagnosis of MERS-CoV infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of MERS-CoV. FilmArray Pneumonia Panel plus MERS-CoV negative results, even in the context of a FilmArray Pneumonia Panel plus positive result for one or more of the common respiratory pathogens, do not preclude MERS-CoV infection and should not be used as the sole basis for patient management decisions. The levels of MERS-CoV that would be present in sputum-like or BAL-like specimens from individuals with early infection and from asymptomatic MERS-CoV carriers are not well understood. A negative FilmArray Pneumonia Panel plus MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious. Viral culture should not be attempted on specimens with positive FilmArray Pneumonia Panel plus results for MERS-CoV unless a BSL 3 facility is available to receive and culture specimens. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 104 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms: the agent(s) 4 detected by the FilmArray Pneumonia Panel plus may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel plus are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi- quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A “Not Detected” result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A “Detected” result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel plus results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel plus, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 104 copies/mL bin if desired, and for antimicrobial susceptibility testing. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): • For prescription use only • For in vitro diagnostic use only 5 Limitations: • For prescription use only. • The FilmArray Pneumonia Panel plus has not been validated for testing of specimens other than unprocessed sputum-like and BAL Purpose for submission:

idK181324_s0_e2000

K181324.txt

measurand

Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ.

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K181324 B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus C. Measurands: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ. D. Type of Test: Qualitative and quantitative nucleic acid amplification assay E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray Pneumonia Panel plus G. Regulatory Information: 1. Regulation section: 21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic acid detection system 2. Classification: Class II (Special Controls) 3. Product code: PZF 2 4. Panel: 83-Microbiology H. Indications for use: 1. Indications for use(s): The FilmArray Pneumonia Panel plus is a multiplexed nucleic acid test intended for use with FilmArray, FilmArray 2.0, or FilmArray Torch systems for the simultaneous detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria. Testing with FilmArray Pneumonia Panel plus should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected MERS-CoV specimens. This includes: clinical signs and symptoms associated with MERS-CoV infection, contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiological links for which MERS- CoV testing may be indicated. The following bacteria are reported semi-qualitatively with bins representing approximately 104, 105, 106, or ≥107 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104, 105, 106, or ≥107 copies/mL Acinetobacter calcoaceticus- baumannii complex Klebsiella oxytoca Serratia marcescens Enterobacter cloacae complex Klebsiella pneumoniae group Staphylococcus aureus Escherichia coli Moraxella catarrhalis Streptococcus agalactiae Haemophilus influenzae Proteus spp. Streptococcus pneumoniae Klebsiella aerogenes Pseudomonas aeruginosa Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: 3 Atypical Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae Viruses Middle East Resipiratory Syndrome Coronavirus Adenovirus Human Rhinovirus/Enterovirus Parainfluenza Virus Coronavirus Influenza A Respiratory Syncytial Virus Human Metapneumovirus Influenza B Antimicrobial Resistance Genes CTX-M NDM mecA/C and MREJ IMP OXA-48-like KPC VIM The detection and identification of specific viral and bacterial nucleic acids from MERS- CoV and other respiratory pathogens, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals meeting MERS-CoV clinical and/or epidemiological criteria aids in the differential diagnosis of MERS-CoV infection, if used in conjunction with other clinical and epidemiological information in accordance with the guidelines provided by the appropriate public health authorities. FilmArray Pneumonia Panel plus MERS-CoV positive results are for the presumptive identification of MERS-CoV. The definitive identification of MERS-CoV requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. The diagnosis of MERS-CoV infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of MERS-CoV. FilmArray Pneumonia Panel plus MERS-CoV negative results, even in the context of a FilmArray Pneumonia Panel plus positive result for one or more of the common respiratory pathogens, do not preclude MERS-CoV infection and should not be used as the sole basis for patient management decisions. The levels of MERS-CoV that would be present in sputum-like or BAL-like specimens from individuals with early infection and from asymptomatic MERS-CoV carriers are not well understood. A negative FilmArray Pneumonia Panel plus MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious. Viral culture should not be attempted on specimens with positive FilmArray Pneumonia Panel plus results for MERS-CoV unless a BSL 3 facility is available to receive and culture specimens. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 104 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms: the agent(s) 4 detected by the FilmArray Pneumonia Panel plus may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel plus are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi- quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A “Not Detected” result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A “Detected” result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel plus results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel plus, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 104 copies/mL bin if desired, and for antimicrobial susceptibility testing. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): • For prescription use only • For in vitro diagnostic use only 5 Limitations: • For prescription use only. • The FilmArray Pneumonia Panel plus has not been validated for testing of specimens other than unprocessed sputum-like and BAL Measurand:

idK181324_s0_e2000

K181324.txt

type of test

Qualitative and quantitative nucleic acid amplification assay

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K181324 B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus C. Measurands: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ. D. Type of Test: Qualitative and quantitative nucleic acid amplification assay E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray Pneumonia Panel plus G. Regulatory Information: 1. Regulation section: 21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic acid detection system 2. Classification: Class II (Special Controls) 3. Product code: PZF 2 4. Panel: 83-Microbiology H. Indications for use: 1. Indications for use(s): The FilmArray Pneumonia Panel plus is a multiplexed nucleic acid test intended for use with FilmArray, FilmArray 2.0, or FilmArray Torch systems for the simultaneous detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria. Testing with FilmArray Pneumonia Panel plus should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected MERS-CoV specimens. This includes: clinical signs and symptoms associated with MERS-CoV infection, contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiological links for which MERS- CoV testing may be indicated. The following bacteria are reported semi-qualitatively with bins representing approximately 104, 105, 106, or ≥107 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104, 105, 106, or ≥107 copies/mL Acinetobacter calcoaceticus- baumannii complex Klebsiella oxytoca Serratia marcescens Enterobacter cloacae complex Klebsiella pneumoniae group Staphylococcus aureus Escherichia coli Moraxella catarrhalis Streptococcus agalactiae Haemophilus influenzae Proteus spp. Streptococcus pneumoniae Klebsiella aerogenes Pseudomonas aeruginosa Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: 3 Atypical Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae Viruses Middle East Resipiratory Syndrome Coronavirus Adenovirus Human Rhinovirus/Enterovirus Parainfluenza Virus Coronavirus Influenza A Respiratory Syncytial Virus Human Metapneumovirus Influenza B Antimicrobial Resistance Genes CTX-M NDM mecA/C and MREJ IMP OXA-48-like KPC VIM The detection and identification of specific viral and bacterial nucleic acids from MERS- CoV and other respiratory pathogens, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals meeting MERS-CoV clinical and/or epidemiological criteria aids in the differential diagnosis of MERS-CoV infection, if used in conjunction with other clinical and epidemiological information in accordance with the guidelines provided by the appropriate public health authorities. FilmArray Pneumonia Panel plus MERS-CoV positive results are for the presumptive identification of MERS-CoV. The definitive identification of MERS-CoV requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. The diagnosis of MERS-CoV infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of MERS-CoV. FilmArray Pneumonia Panel plus MERS-CoV negative results, even in the context of a FilmArray Pneumonia Panel plus positive result for one or more of the common respiratory pathogens, do not preclude MERS-CoV infection and should not be used as the sole basis for patient management decisions. The levels of MERS-CoV that would be present in sputum-like or BAL-like specimens from individuals with early infection and from asymptomatic MERS-CoV carriers are not well understood. A negative FilmArray Pneumonia Panel plus MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious. Viral culture should not be attempted on specimens with positive FilmArray Pneumonia Panel plus results for MERS-CoV unless a BSL 3 facility is available to receive and culture specimens. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 104 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms: the agent(s) 4 detected by the FilmArray Pneumonia Panel plus may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel plus are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi- quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A “Not Detected” result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A “Detected” result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel plus results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel plus, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 104 copies/mL bin if desired, and for antimicrobial susceptibility testing. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): • For prescription use only • For in vitro diagnostic use only 5 Limitations: • For prescription use only. • The FilmArray Pneumonia Panel plus has not been validated for testing of specimens other than unprocessed sputum-like and BAL Type of test:

idK181324_s0_e2000

K181324.txt

classification

Class II

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K181324 B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus C. Measurands: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ. D. Type of Test: Qualitative and quantitative nucleic acid amplification assay E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray Pneumonia Panel plus G. Regulatory Information: 1. Regulation section: 21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic acid detection system 2. Classification: Class II (Special Controls) 3. Product code: PZF 2 4. Panel: 83-Microbiology H. Indications for use: 1. Indications for use(s): The FilmArray Pneumonia Panel plus is a multiplexed nucleic acid test intended for use with FilmArray, FilmArray 2.0, or FilmArray Torch systems for the simultaneous detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria. Testing with FilmArray Pneumonia Panel plus should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected MERS-CoV specimens. This includes: clinical signs and symptoms associated with MERS-CoV infection, contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiological links for which MERS- CoV testing may be indicated. The following bacteria are reported semi-qualitatively with bins representing approximately 104, 105, 106, or ≥107 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104, 105, 106, or ≥107 copies/mL Acinetobacter calcoaceticus- baumannii complex Klebsiella oxytoca Serratia marcescens Enterobacter cloacae complex Klebsiella pneumoniae group Staphylococcus aureus Escherichia coli Moraxella catarrhalis Streptococcus agalactiae Haemophilus influenzae Proteus spp. Streptococcus pneumoniae Klebsiella aerogenes Pseudomonas aeruginosa Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: 3 Atypical Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae Viruses Middle East Resipiratory Syndrome Coronavirus Adenovirus Human Rhinovirus/Enterovirus Parainfluenza Virus Coronavirus Influenza A Respiratory Syncytial Virus Human Metapneumovirus Influenza B Antimicrobial Resistance Genes CTX-M NDM mecA/C and MREJ IMP OXA-48-like KPC VIM The detection and identification of specific viral and bacterial nucleic acids from MERS- CoV and other respiratory pathogens, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals meeting MERS-CoV clinical and/or epidemiological criteria aids in the differential diagnosis of MERS-CoV infection, if used in conjunction with other clinical and epidemiological information in accordance with the guidelines provided by the appropriate public health authorities. FilmArray Pneumonia Panel plus MERS-CoV positive results are for the presumptive identification of MERS-CoV. The definitive identification of MERS-CoV requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. The diagnosis of MERS-CoV infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of MERS-CoV. FilmArray Pneumonia Panel plus MERS-CoV negative results, even in the context of a FilmArray Pneumonia Panel plus positive result for one or more of the common respiratory pathogens, do not preclude MERS-CoV infection and should not be used as the sole basis for patient management decisions. The levels of MERS-CoV that would be present in sputum-like or BAL-like specimens from individuals with early infection and from asymptomatic MERS-CoV carriers are not well understood. A negative FilmArray Pneumonia Panel plus MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious. Viral culture should not be attempted on specimens with positive FilmArray Pneumonia Panel plus results for MERS-CoV unless a BSL 3 facility is available to receive and culture specimens. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 104 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms: the agent(s) 4 detected by the FilmArray Pneumonia Panel plus may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel plus are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi- quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A “Not Detected” result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A “Detected” result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel plus results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel plus, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 104 copies/mL bin if desired, and for antimicrobial susceptibility testing. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): • For prescription use only • For in vitro diagnostic use only 5 Limitations: • For prescription use only. • The FilmArray Pneumonia Panel plus has not been validated for testing of specimens other than unprocessed sputum-like and BAL Classification:

idK181324_s0_e2000

K181324.txt

product code

PZF

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K181324 B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus C. Measurands: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ. D. Type of Test: Qualitative and quantitative nucleic acid amplification assay E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray Pneumonia Panel plus G. Regulatory Information: 1. Regulation section: 21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic acid detection system 2. Classification: Class II (Special Controls) 3. Product code: PZF 2 4. Panel: 83-Microbiology H. Indications for use: 1. Indications for use(s): The FilmArray Pneumonia Panel plus is a multiplexed nucleic acid test intended for use with FilmArray, FilmArray 2.0, or FilmArray Torch systems for the simultaneous detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria. Testing with FilmArray Pneumonia Panel plus should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected MERS-CoV specimens. This includes: clinical signs and symptoms associated with MERS-CoV infection, contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiological links for which MERS- CoV testing may be indicated. The following bacteria are reported semi-qualitatively with bins representing approximately 104, 105, 106, or ≥107 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104, 105, 106, or ≥107 copies/mL Acinetobacter calcoaceticus- baumannii complex Klebsiella oxytoca Serratia marcescens Enterobacter cloacae complex Klebsiella pneumoniae group Staphylococcus aureus Escherichia coli Moraxella catarrhalis Streptococcus agalactiae Haemophilus influenzae Proteus spp. Streptococcus pneumoniae Klebsiella aerogenes Pseudomonas aeruginosa Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: 3 Atypical Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae Viruses Middle East Resipiratory Syndrome Coronavirus Adenovirus Human Rhinovirus/Enterovirus Parainfluenza Virus Coronavirus Influenza A Respiratory Syncytial Virus Human Metapneumovirus Influenza B Antimicrobial Resistance Genes CTX-M NDM mecA/C and MREJ IMP OXA-48-like KPC VIM The detection and identification of specific viral and bacterial nucleic acids from MERS- CoV and other respiratory pathogens, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals meeting MERS-CoV clinical and/or epidemiological criteria aids in the differential diagnosis of MERS-CoV infection, if used in conjunction with other clinical and epidemiological information in accordance with the guidelines provided by the appropriate public health authorities. FilmArray Pneumonia Panel plus MERS-CoV positive results are for the presumptive identification of MERS-CoV. The definitive identification of MERS-CoV requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. The diagnosis of MERS-CoV infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of MERS-CoV. FilmArray Pneumonia Panel plus MERS-CoV negative results, even in the context of a FilmArray Pneumonia Panel plus positive result for one or more of the common respiratory pathogens, do not preclude MERS-CoV infection and should not be used as the sole basis for patient management decisions. The levels of MERS-CoV that would be present in sputum-like or BAL-like specimens from individuals with early infection and from asymptomatic MERS-CoV carriers are not well understood. A negative FilmArray Pneumonia Panel plus MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious. Viral culture should not be attempted on specimens with positive FilmArray Pneumonia Panel plus results for MERS-CoV unless a BSL 3 facility is available to receive and culture specimens. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 104 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms: the agent(s) 4 detected by the FilmArray Pneumonia Panel plus may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel plus are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi- quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A “Not Detected” result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A “Detected” result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel plus results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel plus, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 104 copies/mL bin if desired, and for antimicrobial susceptibility testing. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): • For prescription use only • For in vitro diagnostic use only 5 Limitations: • For prescription use only. • The FilmArray Pneumonia Panel plus has not been validated for testing of specimens other than unprocessed sputum-like and BAL Product code:

idK181324_s0_e2000

K181324.txt

panel

83-Microbiology

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K181324 B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus C. Measurands: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ. D. Type of Test: Qualitative and quantitative nucleic acid amplification assay E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray Pneumonia Panel plus G. Regulatory Information: 1. Regulation section: 21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic acid detection system 2. Classification: Class II (Special Controls) 3. Product code: PZF 2 4. Panel: 83-Microbiology H. Indications for use: 1. Indications for use(s): The FilmArray Pneumonia Panel plus is a multiplexed nucleic acid test intended for use with FilmArray, FilmArray 2.0, or FilmArray Torch systems for the simultaneous detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria. Testing with FilmArray Pneumonia Panel plus should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected MERS-CoV specimens. This includes: clinical signs and symptoms associated with MERS-CoV infection, contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiological links for which MERS- CoV testing may be indicated. The following bacteria are reported semi-qualitatively with bins representing approximately 104, 105, 106, or ≥107 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104, 105, 106, or ≥107 copies/mL Acinetobacter calcoaceticus- baumannii complex Klebsiella oxytoca Serratia marcescens Enterobacter cloacae complex Klebsiella pneumoniae group Staphylococcus aureus Escherichia coli Moraxella catarrhalis Streptococcus agalactiae Haemophilus influenzae Proteus spp. Streptococcus pneumoniae Klebsiella aerogenes Pseudomonas aeruginosa Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: 3 Atypical Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae Viruses Middle East Resipiratory Syndrome Coronavirus Adenovirus Human Rhinovirus/Enterovirus Parainfluenza Virus Coronavirus Influenza A Respiratory Syncytial Virus Human Metapneumovirus Influenza B Antimicrobial Resistance Genes CTX-M NDM mecA/C and MREJ IMP OXA-48-like KPC VIM The detection and identification of specific viral and bacterial nucleic acids from MERS- CoV and other respiratory pathogens, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals meeting MERS-CoV clinical and/or epidemiological criteria aids in the differential diagnosis of MERS-CoV infection, if used in conjunction with other clinical and epidemiological information in accordance with the guidelines provided by the appropriate public health authorities. FilmArray Pneumonia Panel plus MERS-CoV positive results are for the presumptive identification of MERS-CoV. The definitive identification of MERS-CoV requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. The diagnosis of MERS-CoV infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of MERS-CoV. FilmArray Pneumonia Panel plus MERS-CoV negative results, even in the context of a FilmArray Pneumonia Panel plus positive result for one or more of the common respiratory pathogens, do not preclude MERS-CoV infection and should not be used as the sole basis for patient management decisions. The levels of MERS-CoV that would be present in sputum-like or BAL-like specimens from individuals with early infection and from asymptomatic MERS-CoV carriers are not well understood. A negative FilmArray Pneumonia Panel plus MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious. Viral culture should not be attempted on specimens with positive FilmArray Pneumonia Panel plus results for MERS-CoV unless a BSL 3 facility is available to receive and culture specimens. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 104 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms: the agent(s) 4 detected by the FilmArray Pneumonia Panel plus may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel plus are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi- quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A “Not Detected” result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A “Detected” result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel plus results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel plus, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 104 copies/mL bin if desired, and for antimicrobial susceptibility testing. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): • For prescription use only • For in vitro diagnostic use only 5 Limitations: • For prescription use only. • The FilmArray Pneumonia Panel plus has not been validated for testing of specimens other than unprocessed sputum-like and BAL Panel:

idK181324_s0_e2000

K181324.txt

applicant

BioFire Diagnostics, LLC

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K181324 B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus C. Measurands: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ. D. Type of Test: Qualitative and quantitative nucleic acid amplification assay E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray Pneumonia Panel plus G. Regulatory Information: 1. Regulation section: 21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic acid detection system 2. Classification: Class II (Special Controls) 3. Product code: PZF 2 4. Panel: 83-Microbiology H. Indications for use: 1. Indications for use(s): The FilmArray Pneumonia Panel plus is a multiplexed nucleic acid test intended for use with FilmArray, FilmArray 2.0, or FilmArray Torch systems for the simultaneous detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria. Testing with FilmArray Pneumonia Panel plus should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected MERS-CoV specimens. This includes: clinical signs and symptoms associated with MERS-CoV infection, contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiological links for which MERS- CoV testing may be indicated. The following bacteria are reported semi-qualitatively with bins representing approximately 104, 105, 106, or ≥107 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104, 105, 106, or ≥107 copies/mL Acinetobacter calcoaceticus- baumannii complex Klebsiella oxytoca Serratia marcescens Enterobacter cloacae complex Klebsiella pneumoniae group Staphylococcus aureus Escherichia coli Moraxella catarrhalis Streptococcus agalactiae Haemophilus influenzae Proteus spp. Streptococcus pneumoniae Klebsiella aerogenes Pseudomonas aeruginosa Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: 3 Atypical Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae Viruses Middle East Resipiratory Syndrome Coronavirus Adenovirus Human Rhinovirus/Enterovirus Parainfluenza Virus Coronavirus Influenza A Respiratory Syncytial Virus Human Metapneumovirus Influenza B Antimicrobial Resistance Genes CTX-M NDM mecA/C and MREJ IMP OXA-48-like KPC VIM The detection and identification of specific viral and bacterial nucleic acids from MERS- CoV and other respiratory pathogens, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals meeting MERS-CoV clinical and/or epidemiological criteria aids in the differential diagnosis of MERS-CoV infection, if used in conjunction with other clinical and epidemiological information in accordance with the guidelines provided by the appropriate public health authorities. FilmArray Pneumonia Panel plus MERS-CoV positive results are for the presumptive identification of MERS-CoV. The definitive identification of MERS-CoV requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. The diagnosis of MERS-CoV infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of MERS-CoV. FilmArray Pneumonia Panel plus MERS-CoV negative results, even in the context of a FilmArray Pneumonia Panel plus positive result for one or more of the common respiratory pathogens, do not preclude MERS-CoV infection and should not be used as the sole basis for patient management decisions. The levels of MERS-CoV that would be present in sputum-like or BAL-like specimens from individuals with early infection and from asymptomatic MERS-CoV carriers are not well understood. A negative FilmArray Pneumonia Panel plus MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious. Viral culture should not be attempted on specimens with positive FilmArray Pneumonia Panel plus results for MERS-CoV unless a BSL 3 facility is available to receive and culture specimens. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 104 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms: the agent(s) 4 detected by the FilmArray Pneumonia Panel plus may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel plus are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi- quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A “Not Detected” result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A “Detected” result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel plus results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel plus, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 104 copies/mL bin if desired, and for antimicrobial susceptibility testing. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): • For prescription use only • For in vitro diagnostic use only 5 Limitations: • For prescription use only. • The FilmArray Pneumonia Panel plus has not been validated for testing of specimens other than unprocessed sputum-like and BAL Applicant:

idK181324_s0_e2000

K181324.txt

proprietary and established names

FilmArray Pneumonia Panel plus

EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K181324 B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus C. Measurands: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ. D. Type of Test: Qualitative and quantitative nucleic acid amplification assay E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray Pneumonia Panel plus G. Regulatory Information: 1. Regulation section: 21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic acid detection system 2. Classification: Class II (Special Controls) 3. Product code: PZF 2 4. Panel: 83-Microbiology H. Indications for use: 1. Indications for use(s): The FilmArray Pneumonia Panel plus is a multiplexed nucleic acid test intended for use with FilmArray, FilmArray 2.0, or FilmArray Torch systems for the simultaneous detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria. Testing with FilmArray Pneumonia Panel plus should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected MERS-CoV specimens. This includes: clinical signs and symptoms associated with MERS-CoV infection, contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiological links for which MERS- CoV testing may be indicated. The following bacteria are reported semi-qualitatively with bins representing approximately 104, 105, 106, or ≥107 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104, 105, 106, or ≥107 copies/mL Acinetobacter calcoaceticus- baumannii complex Klebsiella oxytoca Serratia marcescens Enterobacter cloacae complex Klebsiella pneumoniae group Staphylococcus aureus Escherichia coli Moraxella catarrhalis Streptococcus agalactiae Haemophilus influenzae Proteus spp. Streptococcus pneumoniae Klebsiella aerogenes Pseudomonas aeruginosa Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: 3 Atypical Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae Viruses Middle East Resipiratory Syndrome Coronavirus Adenovirus Human Rhinovirus/Enterovirus Parainfluenza Virus Coronavirus Influenza A Respiratory Syncytial Virus Human Metapneumovirus Influenza B Antimicrobial Resistance Genes CTX-M NDM mecA/C and MREJ IMP OXA-48-like KPC VIM The detection and identification of specific viral and bacterial nucleic acids from MERS- CoV and other respiratory pathogens, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals meeting MERS-CoV clinical and/or epidemiological criteria aids in the differential diagnosis of MERS-CoV infection, if used in conjunction with other clinical and epidemiological information in accordance with the guidelines provided by the appropriate public health authorities. FilmArray Pneumonia Panel plus MERS-CoV positive results are for the presumptive identification of MERS-CoV. The definitive identification of MERS-CoV requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. The diagnosis of MERS-CoV infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of MERS-CoV. FilmArray Pneumonia Panel plus MERS-CoV negative results, even in the context of a FilmArray Pneumonia Panel plus positive result for one or more of the common respiratory pathogens, do not preclude MERS-CoV infection and should not be used as the sole basis for patient management decisions. The levels of MERS-CoV that would be present in sputum-like or BAL-like specimens from individuals with early infection and from asymptomatic MERS-CoV carriers are not well understood. A negative FilmArray Pneumonia Panel plus MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious. Viral culture should not be attempted on specimens with positive FilmArray Pneumonia Panel plus results for MERS-CoV unless a BSL 3 facility is available to receive and culture specimens. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 104 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms: the agent(s) 4 detected by the FilmArray Pneumonia Panel plus may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel plus are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi- quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A “Not Detected” result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A “Detected” result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel plus results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel plus, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 104 copies/mL bin if desired, and for antimicrobial susceptibility testing. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): • For prescription use only • For in vitro diagnostic use only 5 Limitations: • For prescription use only. • The FilmArray Pneumonia Panel plus has not been validated for testing of specimens other than unprocessed sputum-like and BAL Proprietary and established names:

idK181324_s0_e2000

K181324.txt

regulation section

21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K181324 B. Purpose for Submission: To obtain a substantial equivalence determination for the FilmArray Pneumonia Panel plus C. Measurands: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus, Respiratory Syncytial Virus, CTX-M, IMP, KPC, NDM, OXA-48-like, VIM, mecA/C and MREJ. D. Type of Test: Qualitative and quantitative nucleic acid amplification assay E. Applicant: BioFire Diagnostics, LLC F. Proprietary and Established Names: FilmArray Pneumonia Panel plus G. Regulatory Information: 1. Regulation section: 21 CFR 866.4001 – MERS-CoV and common respiratory pathogens multiplex nucleic acid detection system 2. Classification: Class II (Special Controls) 3. Product code: PZF 2 4. Panel: 83-Microbiology H. Indications for use: 1. Indications for use(s): The FilmArray Pneumonia Panel plus is a multiplexed nucleic acid test intended for use with FilmArray, FilmArray 2.0, or FilmArray Torch systems for the simultaneous detection and identification of nucleic acids from Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria. Testing with FilmArray Pneumonia Panel plus should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected MERS-CoV specimens. This includes: clinical signs and symptoms associated with MERS-CoV infection, contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiological links for which MERS- CoV testing may be indicated. The following bacteria are reported semi-qualitatively with bins representing approximately 104, 105, 106, or ≥107 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104, 105, 106, or ≥107 copies/mL Acinetobacter calcoaceticus- baumannii complex Klebsiella oxytoca Serratia marcescens Enterobacter cloacae complex Klebsiella pneumoniae group Staphylococcus aureus Escherichia coli Moraxella catarrhalis Streptococcus agalactiae Haemophilus influenzae Proteus spp. Streptococcus pneumoniae Klebsiella aerogenes Pseudomonas aeruginosa Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: 3 Atypical Bacteria Chlamydia pneumoniae Legionella pneumophila Mycoplasma pneumoniae Viruses Middle East Resipiratory Syndrome Coronavirus Adenovirus Human Rhinovirus/Enterovirus Parainfluenza Virus Coronavirus Influenza A Respiratory Syncytial Virus Human Metapneumovirus Influenza B Antimicrobial Resistance Genes CTX-M NDM mecA/C and MREJ IMP OXA-48-like KPC VIM The detection and identification of specific viral and bacterial nucleic acids from MERS- CoV and other respiratory pathogens, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals meeting MERS-CoV clinical and/or epidemiological criteria aids in the differential diagnosis of MERS-CoV infection, if used in conjunction with other clinical and epidemiological information in accordance with the guidelines provided by the appropriate public health authorities. FilmArray Pneumonia Panel plus MERS-CoV positive results are for the presumptive identification of MERS-CoV. The definitive identification of MERS-CoV requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (e.g., local or state public health departments, etc.) for whom reporting is necessary. The diagnosis of MERS-CoV infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of MERS-CoV. FilmArray Pneumonia Panel plus MERS-CoV negative results, even in the context of a FilmArray Pneumonia Panel plus positive result for one or more of the common respiratory pathogens, do not preclude MERS-CoV infection and should not be used as the sole basis for patient management decisions. The levels of MERS-CoV that would be present in sputum-like or BAL-like specimens from individuals with early infection and from asymptomatic MERS-CoV carriers are not well understood. A negative FilmArray Pneumonia Panel plus MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious. Viral culture should not be attempted on specimens with positive FilmArray Pneumonia Panel plus results for MERS-CoV unless a BSL 3 facility is available to receive and culture specimens. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 104 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms: the agent(s) 4 detected by the FilmArray Pneumonia Panel plus may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel plus are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi- quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A “Not Detected” result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A “Detected” result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel plus results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel plus, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 104 copies/mL bin if desired, and for antimicrobial susceptibility testing. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): • For prescription use only • For in vitro diagnostic use only 5 Limitations: • For prescription use only. • The FilmArray Pneumonia Panel plus has not been validated for testing of specimens other than unprocessed sputum-like and BAL Regulation section: