# K193397: ADVIA Centaur® Digoxin assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 16, 2021 after 588 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 K931213 (1993). 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)
- K931213: Acs Digoxin Immunoassay, Ciba Corning Diagnostics Corp. (1993) Summary page 4.

## Indications for use
For in vitro diagnostic use in the quantitative determination of digoxin in serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP systems. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K193397
Methodology: https://510kreport.com/methodology