# K962820: Carbamazepine Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Sep 13, 1996 after 56 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) aca® carbamazepine analytical test pack: named in the summary without a submission number

## Most influential descendants
- K061020: Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino Transferase (2006), 0 descendants of its own

## Indications for use
The CRBM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure carbamazepine, an anti-convulsant drug, in plasma or serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.

Source page: https://510kreport.com/device/K962820
Methodology: https://510kreport.com/methodology