# K033007: Bayer Advia Digoxin Assay for the Integrated Module System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Nov 14, 2003 after 49 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 K885226 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912616: Technicon Immuno 1 TM System Additional Analytes, Technicon Instruments Corp. (1991) Summary page 1.
- K885226: Technicon Axon (TM) System, Technicon Instruments Corp. (1989)

## Indications for use
The Buyer ADVLA@IMS TM Digoxin assay is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K033007
Methodology: https://510kreport.com/methodology