# K955444: Abbott Axsm Procainamide Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 2, 1996 after 126 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
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 Procainamide assay: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K955444
Methodology: https://510kreport.com/methodology