# K060773: Online TDM Procainamide

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 23, 2006 after 154 days
- Product code: LAR (Enzyme Immunoassay, Procainamide)
- 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 ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to help ensure proper therapy.

Source page: https://510kreport.com/device/K060773
Methodology: https://510kreport.com/methodology