# K011648: Randox Carbamazepine

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jan 15, 2002 after 231 days
- Product code: KLT (Enzyme Immunoassay, Carbamazepine)
- Device class: 2
- Regulation: 21 CFR 862.3645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K011648
Methodology: https://510kreport.com/methodology