# K031902: Online TDM Carbamazepine

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 17, 2003 after 89 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: 1 generation back to K951595 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K151578: Carbamazepine Gen 4 (2015), 0 descendants of its own

## Indications for use
The ONLINE TOM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. This neuroleptic drug assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of carbamazepine.

Source page: https://510kreport.com/device/K031902
Methodology: https://510kreport.com/methodology