# K983176: Elecsys Myoglobin Stat Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Sep 24, 1998 after 14 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: 2 generations back to K902154 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972513: Tinaquant Myoglobin Assay, Boehringer Mannheim Corp. (1997) Summary page 3.

## Most influential descendants
- K083260: Elecsys Myoglobin Stat, and Elecsys Myoglobin (2009), 0 descendants of its own

## Indications for use
For the in vitro-quantitative determination of myoglobin in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Boehringer Mannheim immunoassay analyzers. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.

Source page: https://510kreport.com/device/K983176
Methodology: https://510kreport.com/methodology