(119 days)
This in vitro method is intended to quantitatively measure the antiepileptic drug valproic acid in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of valproic acid are used to aid in monitoring therapeutic levels of valproic acid to ensure appropriate therapy and in the treatment of valproic acid overdose.
The Bayer ADVIA IMS Valproic Acid method is for in vitro diagnostic use to measure the antiepileptic drug valproic acid in human serum and plasma. Measurements of valproic acid (2-propylpentanoic acid) are used as an aid in the diagnosis and treatment of valproic acid overdose, and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.
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1. Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (ADVIA IMS) | Predicate Device Performance (Centaur) |
|---|---|---|---|
| Minimum Detectable Concentration (MDC) | Lower than or comparable to predicate device. | 0.57 µg/mL | 1.0 µg/mL |
| Imprecision (Total CV%) | Comparable to or better than predicate device (lower CV%). | Level 34.03: 4.4% | |
| Level 70.16: 2.9% | |||
| Level 98.86: 2.0% | Level 22.8: 6.9% | ||
| Level 64.6: 6.1% | |||
| Level 102.7: 6.4% | |||
| Correlation (R value) | High correlation (close to 1) with the predicate device. | 0.997 | N/A (Comparison System) |
| Regression Equation (Slope) | Close to 1 (indicating proportional agreement). | 0.98 | N/A (Comparison System) |
| Regression Equation (Y-intercept) | Close to 0 (indicating minimal constant bias). | 4.9 | N/A (Comparison System) |
| Syx µg/mL (Standard error of estimate) | Low, indicating good agreement between methods. | 3.1 | N/A (Comparison System) |
| Interfering Substances | Effects of interfering substances should be minimal (e.g., % change |
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.