(51 days)
ACE® Valproic Acid Reagent is intended for use in the quantitative determination of valproic acid in human serum.
ACE® Valproic Acid Reagent is intended for the quantitative determination of valproic acid in serum using the ACE® clinical chemistry analyzer.
The ACE® Valproic Acid Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to valproic acid and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
The ACE® Valproic Acid Reagent is an enzyme immunoassay intended for the quantitative determination of valproic acid in human serum. The study demonstrated its substantial equivalence to a predicate device, the DRI Valproic Acid Enzyme Immunoassay, based on performance parameters such as assay range, precision, and correlation with another commercial valproic acid assay.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device and showing comparable performance. The performance metrics of the predicate device serve as the de facto acceptance criteria.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Assay Range | 3 µg/mL to 150 µg/mL | 3.1 µg/mL to 150 µg/mL |
| Precision | ||
| Within-Run %CV |
§ 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.