# K083260: Elecsys Myoglobin Stat, and Elecsys Myoglobin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 16, 2009 after 345 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K902154 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983176: Elecsys Myoglobin Stat Assay, Boehringer Mannheim Corp. (1998) Summary page 2.

## Indications for use
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K083260
Methodology: https://510kreport.com/methodology