# K983323: Digoxin Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Nov 12, 1998 after 51 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Digoxin Immunoassay is intended for in vitro diagnostic use for quantitative determination of digoxin in human serum or plasma. Accurate determination of serum digoxin concentrations provides critical information to the physician, who must determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity.

Source page: https://510kreport.com/device/K983323
Methodology: https://510kreport.com/methodology