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ACE® Phenytoin Reagent is intended for use in the quantitative determination of phenytoin in human serum.
ACE® Phenytoin Reagent is intended for the quantitative determination of phenytoin in serum using the ACE® clinical chemistry analyzer.
Phenytoin is one of the most widely prescribed anti-convulsant drugs for the treatment of epilepsy, particulary grand mal epilepsy (major motor), corticol focal seizures and temporal lobe epilepsy.

The ACE® Phenytoin Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenytoin and is based on the competition of an enzyme glucose-o-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 provided document describes the ACE® Phenytoin Reagent, an enzyme immunoassay for the quantitative determination of phenytoin in human serum, and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The submission relies on demonstrating substantial equivalence to a predicate device (Diagnostic Reagents, Inc. (DRI) - Phenytoin Reagent [510(k) Number K945725]). The performance parameters below are compared between the proposed device and the predicate device, implying that the predicate's performance serves as the de-facto acceptance criteria for the proposed device to be considered substantially equivalent.

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