# K032334: Roche Online TDM Lidocaine

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 12, 2004 after 167 days
- Product code: KLR (Enzyme Immunoassay, Lidocaine)
- Device class: 2
- Regulation: 21 CFR 862.3555
- 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 K954992 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954992: Roche Cobas Integra Reagent Cassettes, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Indications for use
The Roche ONLINE TDM Lidocaine assay is for the quantitative determination of lidocaine in human serum or plasma on automated clinical chemistry analyzers. Lidocaine is an antiarrhythmic agent administered intravenously by either injection or continuous infusion. It is indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Lidocaine reagent kits.

Source page: https://510kreport.com/device/K032334
Methodology: https://510kreport.com/methodology