# K153301: Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 8, 2016 after 147 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: 7 generations back to K931172 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973112: Elecsys Digoxin, Boehringer Mannheim Corp. (1997) Summary page 6.
- K092649: Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160, 04842472-190, Roche Diagnostics Corp. (2010) Summary page 5.

## Indications for use
Immunoassay for the in vitro quantitative determination of digoxin in human serum and plasma. Measurements are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. PreciControl Cardiac II is used for quality control of specified immunoassays on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K153301
Methodology: https://510kreport.com/methodology