# K123518: Abbott Carbamazepine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corporation
- Decided: Jun 5, 2013 after 203 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
Longest line of descent: 2 generations back to K913066 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993028: Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90, Syva Co. (2000) Summary page 1.

## Indications for use
The Abbott Carbamazepine assay is used for the in vitro quantitative measurement of carbamazepine in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.

Source page: https://510kreport.com/device/K123518
Methodology: https://510kreport.com/methodology