# K032332: Roche Online TDM Quinidine

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 12, 2004 after 167 days
- Product code: LBZ (Enzyme Immunoassay, Quinidine)
- Device class: 2
- Regulation: 21 CFR 862.3320
- 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.
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)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.

## Indications for use
The Roche ONLINE TDM Quinidine assay is for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. Quinidine is used for the prevention and treatment of ventricular arrhthmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic serum levels is dependent on the drug formulation, patient age, and individual variability in absorption and metabolism. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Quinidine reagent kits.

Source page: https://510kreport.com/device/K032332
Methodology: https://510kreport.com/methodology