# K980521: Digoxin Assay for the Technicon RA / Opera Systems

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Apr 2, 1998 after 64 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. The FDA summary names its predicate without a number.
- (no number) Bayer Immuno 1 Digoxin method: named in the summary without a submission number

## Indications for use
This in vitro diagnostic procedure is intended to measure the concentration of digoxin in human serum or plasma on a Technicon RA-500®, Technicon RA-1000®, Technicon RA-XT™, Technicon RA-2000®, or opeRA system. Measurements obtained with this procedure are used to monitor circulating levels of this drug so that the proper therapeutic level is maintained while avoiding toxicity.

Source page: https://510kreport.com/device/K980521
Methodology: https://510kreport.com/methodology