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510(k) Data Aggregation
(119 days)
ADVIA IMS CARBAMAZEPINE METHOD
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., |
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