(51 days)
ACE® Primidone Reagent is intended for use in the quantitative determination of primidone in human serum.
ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer.
Primidone (Mysoline®) used alone, or in combination with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.
The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to primidone 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® Primidone Reagent is intended for the quantitative determination of primidone in human serum using the ACE® clinical chemistry analyzer. The device's performance was assessed by comparing it to a predicate device, the DRI Primidone Enzyme Immunoassay, and through non-clinical test results including within-run and between-run precision, and correlation against a Hitachi 717 analyzer.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" as pass/fail thresholds for precision or correlation. Instead, it presents the performance of the proposed device alongside the predicate device's performance for comparison, implying that performance comparable to or better than the predicate is acceptable.
| Parameter | Implied Acceptance Criterion (Compared to Predicate) | Proposed Device Performance | Predicate Device Performance |
|---|---|---|---|
| Assay Range | Comparable or wider range | 0.3 µg/mL to 24 µg/mL | 0.5 µg/mL to 24 µg/mL |
| Precision (Within Run) | Comparable or better (%CV) |
§ 862.3680 Primidone test system.
(a)
Identification. A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.(b)
Classification. Class II.