# K102346: Randox Digoxin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Oct 14, 2011 after 421 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 Randox Laboratories Digoxin Assay is an in vitro diagnostic test for the quantitative determination of Digoxin in human serum or plasma, Quantitative measurements are used in the diagnosis and treatment of Digoxin overdose and in monitoring levels of Digoxin to ensure appropriate therapy.. This device has been developed for the ADVIA system and is intended for prescription use only.

Source page: https://510kreport.com/device/K102346
Methodology: https://510kreport.com/methodology