# K012301: Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Sep 19, 2001 after 61 days
- Product code: KXT (Enzyme Immunoassay, Digoxin)
- 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 K914833 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914833: Immulite Digoxin, Cirrus Diagnostics, Inc. (1991) Summary page 2.

## Indications for use
The IMMULITE® 2000 Digoxin assay is for in vitro diagnostic use with the IMMULITE® 2000 Analyzer — for the quantitative measurement of digoxin in serum or heparinized plasma, as an aid in monitoring the therapeutic administration of this cardioglycoside, while avoiding toxicity.

Source page: https://510kreport.com/device/K012301
Methodology: https://510kreport.com/methodology