# K963062: Immage System Digoxin (Dig) Reagent/Beckman Drug Calibrator 2

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Dec 13, 1996 after 128 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.

## Cited in the summary but kept off the family tree
- K542328: Behring Diagnostics N Latex RF. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Indications for use
The IMMAGE Immunochemistry System Digoxin (DIG) Reegent, in conjunction with Beckman Drug Calibrator 2, is intended for use in the quantitative determination of digoxin in human serum and piasma sampies by turbidimetric immunoaseay. This assay is designed for use with the IMMAGE Immunochemistry System.

Source page: https://510kreport.com/device/K963062
Methodology: https://510kreport.com/methodology