# K060738: TDM N-Acetylprocainamide

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 16, 2006 after 149 days
- Product code: LAN (Enzyme Immunoassay, N-Acetylprocainamide)
- Device class: 2
- Regulation: 21 CFR 862.3320
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Feb 5, 2010 · Not classified · Z-2386-2010: The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct expiration date for the lot is 1/31/2011.

## Indications for use
The ONLINE TDM N-acetylprocainamide assay is for the quantitative determination of N-acetylprocainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained from this device are used in the diagnosis and treatement of N-acetylprocainamide overdose and in monitoring the levels of N-acetylprocainamide to help ensure appropriate therapy.

Source page: https://510kreport.com/device/K060738
Methodology: https://510kreport.com/methodology