# K151578: Carbamazepine Gen 4

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Oct 22, 2015 after 133 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 K951595 (1995). 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)
- K031902: Online TDM Carbamazepine, Roche Diagnostics Corp. (2003) Summary page 4.

## Indications for use
In vitro test for the quantitative determination of carbamazepine in serum and plasma on Roche/Hitachi cobas c systems. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.

Source page: https://510kreport.com/device/K151578
Methodology: https://510kreport.com/methodology