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The ARCHITECT iPhenytoin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenytoin, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of phenytoin to help ensure appropriate therapy. The ARCHITECT iPhenytoin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenytoin in human serum or plasma.

The ARCHITECT iPhenytoin assay is a one-step STAT immunoassay for the quantitative measurement of phenytoin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample, anti-phenytoin coated paramagnetic microparticles, and phenytoin acridinium-labeled conjugate are combined to create a reaction mixture. The antiphenytoin coated microparticles bind to phenytoin present in the sample and to the phenytoin acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of phenytoin in the sample and the RLUs detected by the ARCHITECT i System optics.

Phenytoin is intended for in vitro diagnostic use in the quantitative determination of the phenytoin concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy. TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981647 Phenytoin assay on T60 Analyzer.

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The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Phenytoin reagent kits.

The Abbott Aeroset® Phenytoin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenytoin in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenytoin concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anti-convulsant medication for the following reasons: - Serum phenytoin concentrations correlate better with pharmacologic activity than does . dosage because of individual differences in absorption, metabolism, disease states, concomitant medication, and compliance. Serum concentration monitoring helps physicans individualize dosage regimens. - The hepatic enzyme system for metabolizing phenytoin can become saturated within the . drug's therapeutic range. When this occurs, small dosage alterations can lead to unexpected drug accumulation and clinical toxicity. - Phenytoin is safe and effective only in a narrow range of serum concentrations. . - Methods historically used to monitor serum phenytoin concentrations include . chromatographic assays and immunoassays.

The Abbott Aeroset® Phenytoin Assay is a homogenous enzyme assay intended for use in quantitative analysis of Phenytoin in human serum or plasma.

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.

Immunoassay for the in vitro quantitative determination of phenytoin in human serum and plasma.

The CEDIA® Phenytoin II Assay is based on the bacterial enzyme Bgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, phenytoin in the sample competes with analyte conjugated to one inactive fragment of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.