# K990251: DGTX Flex Reagent Cartridge, Model DF36

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 31, 1999 after 63 days
- Product code: LFM (Enzyme Immunoassay, Digitoxin)
- Device class: 2
- Regulation: 21 CFR 862.3300
- 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 K891094 (1989). 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)
- K891094: Aca (R) Digitoxin (DGTX) Method, E.I. Dupont DE Nemours & Co., Inc. (1989) 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 DGTX Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure digitoxin in human serum and plasma. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K990251
Methodology: https://510kreport.com/methodology