# K983151: Immage Immunochemistry System Digoxin (Dig) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 5, 1998 after 57 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 K882233 (1988). 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)
- K882233: TDX (R) Digoxin NXT, Abbott Laboratories (1988) Summary page 1.

## Indications for use
The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, when used in conjunction with Beckman IMMAGE® Immunochemistry Systems and Beckman Drug Calibrator 2, is intended for the quantitative determination of digoxin in human serum or plasma by turbidimetric immunoassay.

Source page: https://510kreport.com/device/K983151
Methodology: https://510kreport.com/methodology