(138 days)
The Bayer ADVIA IMS Asparate Aminotransferase (AST) assay is an in vitro diagnostic device intended to measure AST activity in human serum or plasma. Sugh measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in vitro diagnostic device intended to measure CK activity in human serum or plasma. Such measurements are used as an aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne's dystrophy.
The Bayer ADVIA IMS Creatinine assay is an in vitro diagnostic device intended to measure creatinine in human serum, plasma or urine. Such measurements are used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes.
The Bayer ADVIA IMS Phenobarbital assay is an in vitro diagnostic device intended to measure phenobarbital in human serum. Measurements of phenobarbital are used as an aid in the diagnosis and treatment of phenobarbital overdose and in monitoring therapeutic levels of phenobarbital to ensure appropriate therapy.
Not Found
Here's a breakdown of the acceptance criteria and study information for each of the four assays (Aspartate Aminotransferase (AST), Creatine Kinase (CK), Creatinine, and Phenobarbital) described in the provided documents.
Given that these are in-vitro diagnostic (IVD) devices for laboratory measurements, many of the typical acceptance criteria and study aspects for AI/ML-based diagnostic devices (like multi-reader multi-case studies, expert adjudication methods, and standalone performance for classification tasks) are not applicable. The studies focus on analytical performance parameters (precision, linearity, correlation with a predicate device, and interference testing) rather than clinical diagnostic accuracy per se.
1. Aspartate Aminotransferase (AST) Method for the ADVIA™ IMS Systems
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Metric (ADVIA IMS) | Reported Performance (ADVIA IMS) | Predicate Device (CHEM 1) Performance | Notes |
|---|---|---|---|---|
| Analytical Range | 0 to 1000 U/L | 0 to 1000 U/L | 0 to 1030 U/L | Demonstrates comparable analytical range. |
| Precision (Total) | % CV at certain mean U/L | 4.2% @ 30 U/L 2.4% @ 63 U/L 1.6% @ 153 U/L | 4.1% @ 31 U/L 2.1% @ 231 U/L 3.6% @ 369 U/L | Demonstrated acceptable precision. Specific acceptance criteria values (max %CV) are not explicitly stated but implied by comparison to predicate. |
| Method Comparison (Serum) | Regression equation, r, Sy.x | $y = 0.99x - 2.8$ $r = 0.998$ $Sy.x = 16.9$ U/L Range = 16 to 910 U/L (n=66) | Not applicable (predicate for comparison) | Strong correlation to the predicate device. Specific acceptance criteria for r and Sy.x (e.g., >0.98, within a certain range for Sy.x) are not stated but these results are typically considered excellent. |
| Method Comparison (Plasma Qualification) | Regression equation, r, Sy.x | $y = 0.975x + 0.7$ $r = 0.997$ $Sy.x = 0.77$ U/L Range = 14 to 69 U/L (n=53) | Not applicable (comparison plasma vs serum) | Strong correlation between plasma and serum samples. |
| Interference | % Change from baseline | Hemolysis: 59% @ 90 U/L (500 mg/dL Hemoglobin) Conjugated Bilirubin: -3% @ 89 U/L (20 mg/dL) Unconjugated Bilirubin: 0% @ 88 U/L (25 mg/dL) Lipemia: 3% @ 96 U/L (500 mg/dL Triglycerides) | Not provided for predicate | These values are reported effects. Acceptance criteria would typically define a maximum allowable % change (e.g., +/- 10%). The 59% change for hemolysis is significant and often noted as an interference. |
2. Sample size used for the test set and the data provenance
- Serum Correlation: n = 66
- Plasma Qualification: n = 53
- Precision and Interference: Sample sizes for these specific tests are not explicitly stated but are typically performed on a limited number of human or spiked samples/controls.
- Data Provenance: Not explicitly stated, but clinical samples would be human serum/plasma. Retrospective or prospective is not specified. Country of origin not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For an IVD assay measuring analytes like AST, the "ground truth" is established by the reference method (the predicate device in this case) or by highly characterized control materials, not by expert interpretation.
4. Adjudication method for the test set
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is an IVD assay, not an AI/ML-based diagnostic system requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicable. The entire study describes the standalone performance of the ADVIA IMS AST method. It's an automated chemical assay, so its performance is inherently "standalone" in this context. The results in the table reflect this standalone performance.
7. The type of ground truth used
- For Method Comparison (Serum): The predicate device (Bayer CHEM® 1 AST method) served as the reference for comparison, effectively the "ground truth" for demonstrating substantial equivalence.
- For Precision and Analytical Range: The ground truth is typically established by known concentrations of control materials or linearity standards.
- For Interference: Ground truth is the known concentration of the analyte in the absence of the interferent, often compared to the reading in the presence of spiked interferent.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set. The assay's parameters are determined through chemical and mechanical engineering, and tested with validation samples.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
2. Creatine Kinase (CK) Method for the ADVIA™ IMS Systems
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Metric (ADVIA IMS) | Reported Performance (ADVIA IMS) | Predicate Device (CHEM 1) Performance | Notes |
|---|---|---|---|---|
| Analytical Range | 0 to 2200 U/L | 0 to 2200 U/L | 0 to 2200 U/L | Demonstrates comparable analytical range. |
| Precision (Total) | % CV at certain mean U/L | 1.9% @ 97 U/L 1.3% @ 231 U/L 1.3% @ 562 U/L | 2.0% @ 142 U/L 2.9% @ 407 U/L 2.3% @ 457 U/L | Demonstrated acceptable precision. Specific acceptance criteria values are not explicitly stated but implied by comparison. |
| Method Comparison (Serum) | Regression equation, r, Sy.x | $y = 0.99x + 2.7$ $r = 0.999$ $Sy.x = 18.2$ U/L Range = 4 to 1873 U/L (n=67) | Not applicable (predicate for comparison) | Strong correlation to the predicate device. Results are in an excellent range. |
| Method Comparison (Plasma Qualification) | Regression equation, r, Sy.x | $y = 1.01x - 0.3$ $r = 0.999$ $Sy.x = 2.8$ U/L Range = 37 to 472 U/L (n=60) | Not applicable (comparison plasma vs serum) | Strong correlation between plasma and serum samples. |
| Interference | % Change from baseline | Hemoglobin: 28% @ 113 U/L (500 mg/dL Hemoglobin) Conjugated Bilirubin: -2% @ 112 U/L (20 mg/dL) Unconjugated Bilirubin: 0% @ 109 U/L (25 mg/dL) Lipemia: -4% @ 114 U/L (500 mg/dL Triglycerides) | Not provided for predicate | Reported effects. The 28% change for hemoglobin is significant and typically recognized as an interference. |
2. Sample size used for the test set and the data provenance
- Serum Correlation: n = 67
- Plasma Qualification: n = 60
- Precision and Interference: Sample sizes are not explicitly stated but are typically performed on a limited number of human or spiked samples/controls.
- Data Provenance: Not explicitly stated, but clinical samples would be human serum/plasma. Retrospective or prospective not specified. Country of origin not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See AST section point 3.
4. Adjudication method for the test set
- Not Applicable. See AST section point 4.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. See AST section point 5.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicable. The entire study describes the standalone performance of the ADVIA IMS CK method.
7. The type of ground truth used
- For Method Comparison (Serum): The predicate device (Bayer CHEM® 1 CK method) served as the reference for comparison.
- For Precision and Analytical Range: The ground truth is typically established by known concentrations of control materials or linearity standards.
- For Interference: Ground truth is the known concentration of the analyte in the absence of the interferent.
8. The sample size for the training set
- Not Applicable. See AST section point 8.
9. How the ground truth for the training set was established
- Not Applicable. See AST section point 9.
3. Creatinine Method for the ADVIA™ IMS Systems
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Metric (ADVIA IMS) | Reported Performance (ADVIA IMS) | Predicate Device (CHEM 1) Performance | Notes |
|---|---|---|---|---|
| Analytical Range (Serum) | 0 to 30 mg/dL | 0 to 30 mg/dL | 0.3 to 29 mg/dL | Comparable analytical range for serum. |
| Analytical Range (Urine) | 0 to 300 mg/dL | 0 to 300 mg/dL | 2.4 to 232 mg/dL (or 0.3-29 mg/dL undiluted) | Comparable analytical range for urine. |
| Imprecision (Serum) | % CV at certain mean mg/dL | 2.96% @ 1.10 mg/dL 2.99% @ 2.82 mg/dL 1.70% @ 5.67 mg/dL | 5.6% @ 1.3 mg/dL 2.3% @ 9.0 mg/dL 2.6% @ 15.1 mg/dL | Demonstrated acceptable precision. |
| Imprecision (Urine) | % CV at certain mean mg/dL | 2.89% @ 63.80 mg/dL 2.33% @ 111.30 mg/dL 2.13% @ 155.0 mg/dL | 3.5% @ 31 mg/dL 3.3% @ 51 mg/dL 4.1% @ 119 mg/dL | Demonstrated acceptable precision. |
| Correlation (Serum) | Regression equation, r, Sy.x | $y = 0.96x + 0.38$ $r = 0.999$ $Sy.x = 0.31$ mg/dL (n=108, 54 samples in duplicate) Range = 0.4 to 28.9 mg/dL | Not applicable (predicate for comparison) | Excellent correlation to the predicate device. |
| Correlation (Plasma Qualification) | Regression equation, r, Sy.x | $y = 0.96x + 0.05$ $r = 0.98$ $Sy.x = 0.03$ mg/dL (n=119, 60 samples in duplicate) Range = 0.69 to 1.55 mg/dL | Not applicable (comparison plasma vs serum) | Strong correlation between plasma and serum samples. |
| Correlation (Urine) | Regression equation, r, Sy.x | $y = 1.01x - 0.06$ $r = 0.998$ $Sy.x = 4.01$ mg/dL (n=102, 51 samples in duplicate) Range = 7 to 352 mg/dL | Not applicable (predicate for comparison) | Excellent correlation to the predicate device. |
| Interference (Serum) | % Change from baseline | Hemoglobin: +7% @ 2.98 mg/dL (1000 mg/dL) Conjugated Bilirubin: -8% @ 2.94 mg/dL (18.8 mg/dL) Unconjugated Bilirubin: -5% @ 3.02 mg/dL (25 mg/dL) Lipemia: -2% @ 3.08 mg/dL (1000 mg/dL) | Not provided for predicate | These reported effects are within commonly accepted clinical interference limits (e.g., +/- 10%). |
| Interference (Urine) | % Change from baseline | Ascorbic Acid: <1% @ 60.36 mg/dL (220 mg/dL) Acetaminophen: <1% @ 52.97 mg/dL (60 mg/dL) Salicylic Acid: <1% @ 56.02 mg/dL (550 mg/dL) | Not provided for predicate | These effects are negligible. |
2. Sample size used for the test set and the data provenance
- Serum Correlation: n = 108 (54 samples in duplicate)
- Plasma Qualification: n = 119 (60 samples in duplicate)
- Urine Correlation: n = 102 (51 samples in duplicate)
- Imprecision and Interference: Sample sizes are not explicitly stated but are typically performed on a limited number of human or spiked samples/controls.
- Data Provenance: Not explicitly stated, but clinical samples would be human serum/plasma/urine. Retrospective or prospective not specified. Country of origin not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See AST section point 3.
4. Adjudication method for the test set
- Not Applicable. See AST section point 4.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. See AST section point 5.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicable. The entire study describes the standalone performance of the ADVIA IMS Creatinine method.
7. The type of ground truth used
- For Method Comparison (Serum/Urine): The predicate device (Bayer Chem 1® Creatinine method) served as the reference for comparison.
- For Precision and Analytical Range: The ground truth is typically established by known concentrations of control materials or linearity standards.
- For Interference: Ground truth is the known concentration of the analyte in the absence of the interferent.
8. The sample size for the training set
- Not Applicable. See AST section point 8.
9. How the ground truth for the training set was established
- Not Applicable. See AST section point 9.
4. Phenobarbital Method for the Bayer ADVIA® IMS Systems
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Metric (ADVIA IMS) | Reported Performance (ADVIA IMS) | Predicate Device (Technicon RA-1000) Performance | Notes |
|---|---|---|---|---|
| Minimum Detection Concentration | 0.49 µg/mL | 0.49 µg/mL | 0.9 µg/mL | The ADVIA IMS method shows a lower (better) minimum detection concentration than the predicate. |
| Precision (Total) | % CV at certain mean µg/mL | 4.8% @ 14.7 µg/mL 5.1% @ 24.9 µg/mL 3.4% @ 40.3 µg/mL | 3.0% @ 9.0 µg/mL 2.6% @ 23.0 µg/mL 2.7% @ 44.0 µg/mL | Precision is comparable but slightly higher %CV for ADVIA IMS at certain levels compared to the predicate. Specific acceptance criteria not stated. |
| Correlation | Regression equation, r, Sy.x | $y = 0.98x + 0.80$ $r = 0.992$ $Sy.x = 1.23$ µg/mL (n=52) | Not applicable (predicate for comparison) | Strong correlation to the predicate device. |
| Interference | % Change from baseline | Unconjugated Bilirubin: +2% @ 15.5 µg/mL (25 mg/dL) Conjugated Bilirubin: -2% @ 15.9 µg/mL (20 mg/dL) Hemoglobin: -5% @ 19.7 µg/mL (600 mg/dL) Lipemia: -3% @ 19.6 µg/mL (1000 mg/dL) | Not provided for predicate | These reported effects are well within commonly accepted clinical interference limits (e.g., +/- 10%). |
2. Sample size used for the test set and the data provenance
- Correlation: n = 52
- Precision and Interference: Sample sizes for these specific tests are not explicitly stated but are typically performed on a limited number of human or spiked samples/controls.
- Data Provenance: Not explicitly stated, but clinical samples would be human serum. Retrospective or prospective not specified. Country of origin not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See AST section point 3.
4. Adjudication method for the test set
- Not Applicable. See AST section point 4.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. See AST section point 5.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicable. The entire study describes the standalone performance of the ADVIA IMS Phenobarbital method.
7. The type of ground truth used
- For Correlation: The predicate device (Technicon RA-1000 method) served as the reference for comparison.
- For Precision and Minimum Detection Concentration: The ground truth is typically established by known concentrations of control materials or linearity standards.
- For Interference: Ground truth is the known concentration of the analyte in the absence of the interferent.
8. The sample size for the training set
- Not Applicable. See AST section point 8.
9. How the ground truth for the training set was established
- Not Applicable. See AST section point 9.
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Aspartate Aminotransferase (AST) Method for the ADVIA™ IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA IMS Aspartate Ammotransferase (AST) method and a similar device that was granted clearance of substantial equivalence (Bayer CHEM® 1 AST method). The information was extracted from the Bayer ADVIA IMS AST method and Bayer CHEM 1 AST method sheet.
INTENDED USE
The Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay is an in-vitro diagnostic device intended to measure AST in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain liver diseases and heart diseases.
| AST METHOD: | ADVIA IMS | CHEM 1 |
|---|---|---|
| Part Number: | Reagents B41-3722-23 | T01-1631-53 |
| Analytical Range: | 0 to 1000 U/L | 0 to 1030 U/L |
| Precision (Total): | mean (U/L) | % CV |
| 30 | 4.2 | |
| 63 | 2.4 | |
| 153 | 1.6 | |
| mean (U/L) | % CV | |
| 31 | 4.1 | |
| 231 | 2.1 | |
| 369 | 3.6 | |
| Regression Equation: (serum) | $y = 0.99x - 2.8$ | |
| where: | y = ADVIA IMSx = Chem 1n = 66r = 0.998Sy.x = 16.9range = 16 to 910 U/L | |
| Regression Equation: (plasma qualification) | $y = 0.975x + 0.7$ | |
| where: | y = plasmax = serumn = 53r = 0.997Sy.x = 0.77range = 14 to 69 U/L |
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| Interfering SubstanceConcentration | AST(U/L) | Effect% Change | |
|---|---|---|---|
| Hemolysis (Hemoglobin) | 500 mg/dL | 90 | 59 |
| Bilirubin (conjugated) | 20 mg/dL | 89 | -3 |
| Bilirubin (unconjugated) | 25 mg/dL | 88 | 0 |
| Lipemia (Triglycerides) | 500 mg/dL | 96 | 3 |
Gabriel J. Murray Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
Date 6/22/99
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Creatine Kinase (CK) Method for the ADVIA™ IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA IMS Creatine Kinase (CK) method and a similar device that was granted clearance of substantial equivalence (Bayer CHEM 1® CK method). The information was extracted from the Bayer ADVIA IMS CK method and Bayer CHEM 1 CK method sheet.
INTENDED USE
The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in-vitro diagnostic device intended to measure CK in human serum or plasma. Such measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases.
| CK METHOD: | ADVIA IMS | CHEM 1 | ||
|---|---|---|---|---|
| Part Number: | Reagents B41-3729-23 | T01-1491-53 | ||
| Analytical Range: | 0 to 2200 U/L | 0 to 2200 U/L | ||
| Precision (Total): | mean(U/L) | % CV | mean(U/L) | % CV |
| 97 | 1.9 | 142 | 2.0 | |
| 231 | 1.3 | 407 | 2.9 | |
| 562 | 1.3 | 457 | 2.3 | |
| Regression Equation:(serum) | y = 0.99x + 2.7 | |||
| where: | y | = ADVIA IMS | ||
| x | = Chem 1 | |||
| n | = 67 | |||
| r | = 0.999 | |||
| Sy.x | = 18.2 | |||
| range | = 4 to 1873 U/L | |||
| Regression Equation:(plasma qualification) | y = 1.01x - 0.3 | |||
| where: | y | = plasma | ||
| x | = serum | |||
| n | = 60 | |||
| r | = 0.999 | |||
| Sy.x | = 2.8 | |||
| range | = 37 to 472 U/L |
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| Interfering SubstanceConcentration | CK(U/L) | Effect% Change | |
|---|---|---|---|
| Hemoglobin | 500 mg/dL | 113 | 28 |
| Bilirubin (conjugated) | 20 mg/dL | 112 | -2 |
| Bilirubin (unconjugated) | 25 mg/dL | 109 | 0 |
| Lipemia (Triglycerides) | 500 mg/dL | 114 | -4 |
Gabriel A. Munoz Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/22/99
Date
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Creatinine Method for the ADVIA™ IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA Creatinine method and a similar device that was granted clearance of substantial equivalence (Bayer Chem 1® Creatinine method). The information was extracted from the Bayer ADVIA IMS Creatinine method sheet.
INTENDED USE
The Bayer ADVIA IMS Creatinine assay is an in-vitro diagnostic device intended to measure Creatinine in human serum, plasma, or urine. Such measurements are used in the diagnosis, monitoring and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes.
SERUM
| CREATININEMETHOD: | ADVIA IMS | CHEM 1 | ||
|---|---|---|---|---|
| Part Number: | Reagents B41-3730-46Calibrators T03-1291-62 | T01-1456-53T03-1291-62 | ||
| Analytical Range: | 0 to 30 mg/dL | 0.3 to 29 mg/dL | ||
| Imprecision (Total): | Mean(mg/dL) | % CV | ||
| Level 1 | 1.10 | 2.96 | 1.3 | 5.6 |
| Level 2 | 2.82 | 2.99 | 9.0 | 2.3 |
| Level 3 | 5.67 | 1.70 | 15.1 | 2.6 |
| Correlation to existing system | |
|---|---|
| Regression Equation: y = 0.96x + 0.38 | |
| where: | y = ADVIA IMS |
| x = Chem 1 | |
| n = 108 (54 samples in duplicate) | |
| r = 0.999 | |
| Sy.x = .31 | |
| range = 0.4 to 28.9 mg/dL |
Gabriel J. Munoz Jr.
6/22/99
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| Plasma Qualification | |
|---|---|
| Regression Equation: y=0.96X +0.05 | |
| where: | y = plasma |
| x = serum | |
| n = 119 (60 samples in duplicate) | |
| r = 0.98 | |
| Sy.x = 0.03 | |
| range = .69 to 1.55 mg/dL |
| Interfering SubstanceConcentration | CreatinineConcentration | Effect% Change | |
|---|---|---|---|
| Hemoglobin | 1000 mg/dL | 2.98 mg/dL | +7 |
| Bilirubin (conjugated) | 18.8 mg/dL | 2.94 mg/dL | -8 |
| Bilirubin (unconjugated) | 25 mg/dL | 3.02 mg/dL | -5 |
| Lipemia (Triglycerides) | 1000 mg/dL | 3.08 mg/dL | -2 |
URINE
| CREATININEMETHOD: | ADVIA IMS | CHEM 1 |
|---|---|---|
| Part Number: | Reagents B41-3730-46Calibrators T03-1291-62 | T01-1456-53T03-1291-62 |
| Analytical Range: | 0 to 300 mg/dL | 2.4 to 232 mg/dL(0.3 mg/dL to 29.0mg/dL for undiluted samples) |
| Imprecision (Total): | Mean(mg/dL) | mean(mg/dL) |
| % CV | % CV | |
| Level 1 | 63.802.89 | 313.5 |
| Level 2 | 111.302.33 | 513.3 |
| Level 3 | 155.02.13 | 1194.1 |
Gabriel J. Munoz, Jr.
6/22/99
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| Correlation to existing system | |
|---|---|
| Regression Equation: $y = 1.01x - 0.06$ | |
| where: | |
| y | = ADVIA IMS |
| x | = Chem 1 |
| n | = 102 (51 samples in duplicate) |
| r | = 0.998 |
| Sy.x | = 4.01 |
| range | = 7 to 352 mg/dL |
| Interfering SubstanceConcentration | CreatinineConcentration | Effect% Change | |
|---|---|---|---|
| Ascorbic Acid | 220 mg/dL | 60.36 mg/dL | <1% |
| Acetaminophen | 60 mg/dL | 52.97 mg/dL | <1% |
| Salicylic Acid | 550 mg/dL | 56.02 mg/dL | <1% |
Gabriel J. Muraco Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/22/99
Date
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Phenobarbital Method for the Bayer ADVIA® IMS Systems
Listed below is a comparison of the performance between the Bayer ADVIA IMS Phenobarbital method and a similar device that was granted clearance of substantial equivalence (Technicon RA-1000 method), The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS Phenobarbital method sheet and the RA-1000 method sheet.
INTENDED USE
This in vitro method is intended to quantitatively measure phenobarbital in human serum on the Bayer ADVIA IMS systems. Measurements of phenobarbital are used to aid in the diagnosis and treatment of phenobarbital overdose, patient compliance and to monitor serum levels of phenobarbital to ensure appropriate therapy.
| METHOD | ADVIA IMS | RA-1000 | |
|---|---|---|---|
| Part No. | Part No. | ||
| Reagents | B41-3760-41 | T01-2952-01 | |
| Calibrators | B46-4091-01 | T03-2953-01 | |
| Minimum Det. | Conc. 0.49 µg/mL | 0.9 µg/mL | |
| Precision (Total) | |||
| 4.8% @ 14.7 µg/mL5.1% @ 24.9 µg/mL3.4% @ 40.3 µg/mL | 3.0% @ 9.0 µg/mL2.6% @ 23.0 µg/mL2.7% @ 44.0 µg/mL | ||
| Correlation | $y = 0.98x + 0.80$where y = ADVIA IMS, x = RA-1000n = 52r = 0.992Syx = 1.23 µg/mL |
Interferences
| Interfering Substance | Interfering SubstanceConcentration | PhenobarbitalConcentration, μg/mL | Effect,% Change |
|---|---|---|---|
| Bilirubin (unconjugated) | 25 mg/dL | 15.5 | +2 |
| Bilirubin (conjugated) | 20 mg/dL | 15.9 | -2 |
| Hemoglobin | 600 mg/dL | 19.7 | -5 |
| Lipemia (Triglycerides) | 1000 mg/dL | 19.6 | -3 |
Gabriel J. Munacy, Jr.
6/27/66
6/22/99
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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines above and below, resembling a bird in flight or water waves. The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 9 1999
Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corp. Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097
Re: K992136
Trade Name: 4 Additional Assays for the Bayer ADVIA® Integrated Modular System (IMS) Regulatory Class: II Product Code: CIT, CGX, DLZ, JLB Dated: September 3, 1999 Received: September 7, 1999
Dear Mr. Muraca:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 6
Page Page of
510(k) Number (if known): K992136
Device Name: Bayer ADVIA® Integrated Modular System (IMS)
Indications For Use:
The Bayer ADVIA IMS Asparate Aminotransferase (AST) assay is an in vitro diagnostic device intended to measure AST activity in human serum or plasma. Sugh measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in vitro diagnostic device intended to measure CK activity in human serum or plasma. Such measurements are used as an aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne's dystrophy.
The Bayer ADVIA IMS Creatinine assay is an in vitro diagnostic device intended to measure creatinine in human serum, plasma or urine. Such measurements are used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes.
The Bayer ADVIA IMS Phenobarbital assay is an in vitro diagnostic device intended to measure phenobarbital in human serum. Measurements of phenobarbital are used as an aid in the diagnosis and treatment of phenobarbital overdose and in monitoring therapeutic levels of phenobarbital to ensure appropriate therapy.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
sion of Clinical Laboratory Devices
her A992136
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.