# K971713: N-Acetylprocainamide Assay for the Bayer Immuno 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jun 11, 1997 after 33 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) Syva EMIT® N-Acetylprocainamide Assay: named in the summary without a submission number

## Indications for use
This in vitro diagnostic procedure is intended to quantitatively measure N-acetylprocainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno 1™ system. Measurements of N-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of N-acetylprocainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.

Source page: https://510kreport.com/device/K971713
Methodology: https://510kreport.com/methodology