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510(k) Data Aggregation
(119 days)
The Bayer ADVIA IMS Carbamazepine method is for in vitro diagnostic use to measure the antiepileptic drug carbamazepine in human serum and plasma. Measurements of carbamazepine are used as an aid in the diagnosis and treatment of carbamazepine overdose, and used as an aid in monitoring therapeutic levels of carbamazepine to ensure appropriate therapy.
The Bayer ADVIA IMS Carbamazepine calibrator is for in vitro diagnostic use in the calibration of carbamazepine using the ADVIA® IMS system.
This in vitro method is intended to quantitatively measure the antiepileptic drug carbamazepine in human serum and plasma on the Bayer ADVIA® IMS systems.
1. Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (ADVIA IMS) | Predicate Device Performance (Bayer Centaur) |
|---|---|---|---|
| Minimum Detectable Concentration (MDC) | Lower is better | 0.20 µg/mL | 0.25 µg/mL |
| Imprecision: Level 2.62 µg/mL (Total CV%) | Lower is better | 4.6% | 9.2% (at 3.28 µg/mL) |
| Imprecision: Level 5.63 µg/mL (Total CV%) | Lower is better | 2.6% | 8.2% (at 5.79 µg/mL) |
| Imprecision: Level 9.19 µg/mL (Total CV%) | Lower is better | 2.5% | 8.4% (at 9.85 µg/mL) |
| Correlation (R) | Close to 1.0 | 0.988 | - |
| Regression Equation | Close to Y=1.00X + 0.00 | Y=1.00X + 0.01 | - |
| Syx (Standard Error of the Estimate) | Lower is better | 0.80 µg/mL | - |
| Analytical Range | Wider is better | 0.20 µg/mL to 22.14 µg/mL | - |
| Interfering Substances: Bilirubin (unconjugated) % change | Minimal (e.g., < +/-10%) | 2.0% | - |
| Interfering Substances: Bilirubin (conjugated) % change | Minimal (e.g., < +/-10%) | -3.9% | - |
| Interfering Substances: Hemoglobin % change | Minimal (e.g., < +/-10%) | -0.7% | - |
| Interfering Substances: Lipids % change | Minimal (e.g., < +/-10%) | -8.4% | - |
The acceptance criteria are not explicitly stated as numerical thresholds in the provided document, but are implied by demonstrating performance that is comparable to or better than the predicate device and showing minimal impact from interfering substances. The ADVIA IMS device generally shows better or comparable performance to the Bayer Centaur predicate device across the measured metrics.
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Correlation Study: 48 serum specimens were used for the correlation study against the Centaur comparison system.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It is implied to be from a laboratory setting.
3. Number of Experts and Qualifications for Ground Truth
- This type of in-vitro diagnostic device (IVD) for quantitative measurement does not typically involve expert review for ground truth in the same way imaging or diagnostic algorithms do. The "ground truth" for these studies is the measurement obtained from a well-established, often predicate, device or a reference method. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth is not applicable here.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation, often in imaging or clinical trials. For a quantitative IVD device like this, the performance is assessed against a numerical "reference standard" or a predicate device. Therefore, no adjudication method was used or needed in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a quantitative automated assay, so human interpretation in the same manner as an imaging study is not involved.
6. Standalone (Algorithm Only) Performance Study
- Yes, the performance data presented (MDC, Imprecision, Correlation, Interfering Substances, Analytical Range) represents the standalone performance of the ADVIA IMS Carbamazepine method. It is an automated system, and these metrics directly reflect its capabilities without human intervention in the measurement process.
7. Type of Ground Truth Used
- The ground truth for this study was established using a comparison system, specifically the Bayer Centaur. For the correlation study, the measurements from the Centaur system served as the reference standard against which the ADVIA IMS system was evaluated. For other metrics like MDC and Imprecision, the reference for "truth" comes from established analytical methods and statistical calculations within the laboratory environment.
8. Sample Size for the Training Set
- The document does not provide information on the sample size used for the training set. This information is typically proprietary to the manufacturer and not always included in 510(k) summaries, especially for established IVD technologies.
9. How Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established. For quantitative IVDs, the "training" (calibration and optimization) of the assay would typically involve using known concentration standards (calibrators) and reference materials with established values. These standards are rigorously prepared and validated.
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