# K032573: Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 31, 2003 after 72 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
Longest line of descent: 1 generation back to K833384 (1983). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833384: Procainamide Analytical Test Pack, E.I. Dupont DE Nemours & Co., Inc. (1983) Summary page 1.

## Most influential descendants
- K061655: Dimension Vista Flex Reagent Cartridges (2006), 1 descendant of its own
- K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own

## Indications for use
The Dade Behring Dimension@ Procainamide (PROC) Flex@ reagent cartridge method is used to measure procainamide in serum or plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to emure appropriate therapy.

Source page: https://510kreport.com/device/K032573
Methodology: https://510kreport.com/methodology