(172 days)
The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers. Lamotrigine concentrations can be used as an aid in management of patients treated with lamotrigine.
The ARKTM Lamotrigine Calibrator is intended for use in calibration of the ARK Lamotrigine Assay.
The ARKTM Lamotrigine Control is intended for use in quality control of the ARK Lamotrigine Assay.
The ARK Lamotrigine Assay is a homogeneous immunoassay based on competition between drug in the specimen and lamotrigine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenyzme NAD functions only with the bacterial enzyme used in the assay.
The ARK Lamotrigine Assay consists of reagents R1 anti-lamotrigine polyclonal antibody with substrate and R2 lamotrigine labeled with bacterial G6PDH enzyme. The ARK Lamotrigine Calibrator consists of a six-level set to calibrate the assay, and the ARK Lamotrigine Control consists of a three-level set used for quality control of the assay.
The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lamotrigine in human serum or plasma. The device performance was evaluated through various studies, including limit of quantitation (LOQ), assay range, recovery, linearity, method comparison, precision, interfering substances, specificity, and anticoagulant studies.
1. Acceptance Criteria and Reported Device Performance:
| Study/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) |
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.