# K955422: Axsym N-Acetylprocainamide

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 24, 1996 after 148 days
- Product code: LAN (Enzyme Immunoassay, N-Acetylprocainamide)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TDx/TDxFLx N-Acetylprocainamide assay: named in the summary without a submission number

## Indications for use
The intended use of both assays is for the quantitative determination of N-acetylprocainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).

Source page: https://510kreport.com/device/K955422
Methodology: https://510kreport.com/methodology