# K032564: Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 31, 2003 after 72 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
Longest line of descent: 1 generation back to K833378 (1983). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833378: N-Acetylprocainamide Aca-Analytical, E.I. Dupont DE Nemours & Co., Inc. (1983) Summary page 1.

## Most influential descendants
- K062024: Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge (2006), 0 descendants of its own

## Indications for use
The Dade Behring Dimension0 N-acetylprocainamide (NAPA) Flex@ reagent cartridge method is used to measure N-acetylprocainamide in serum or plasma. Measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.

Source page: https://510kreport.com/device/K032564
Methodology: https://510kreport.com/methodology