(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.
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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: |
§ 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.