(231 days)
The Randox Laboratories Ltd. Carbamazepine Test Kit is an in vitro diagnostic reagent for the quantitative determination of carbamazepine in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with carbamazepine which, in the presence of carbamazepine antibody solution, rapidly agglutinate. When a sample containing carbamazepine is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of carbamazepine in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of carbamazepine in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine use or overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.
These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Ltd. Carbamazepine Test Kit is an in vitro diagnostic reagent for the quantitative determination of carbamazepine in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with carbamazepine which, in the presence of carbamazepine antibody solution, rapidly agglutinate. When a sample containing carbamazepine is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of carbamazepine in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of carbamazepine in the sample.
The provided document is a 510(k) clearance letter from the FDA for a Carbamazepine test kit. It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performs as safely and effectively. However, it does not detail the specific performance metrics or studies used to demonstrate this equivalence.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.
§ 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.