# K972513: Tinaquant Myoglobin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 28, 1997 after 21 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: 1 generation back to K902154 (1990). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902154: NA Latex Myoglobin Test, Behring Diagnostics, Inc. (1990) Summary page 3.

## Most influential descendants
- K061683: Tina-Quant Myoglobin Gen.2 Test System (2006), 1 descendant of its own
- K983176: Elecsys Myoglobin Stat Assay (1998), 1 descendant of its own
- K123785: Diazyme Myoglobin; Assay, Calibrator Set, Control Set (2013), 0 descendants of its own
- K083260: Elecsys Myoglobin Stat, and Elecsys Myoglobin (2009), 0 descendants of its own

## Indications for use
The Tina-quant® Myoglobin Assay is an immunoturbidometric assay for the quantitative determination of Myoglobin in serum and plasma using automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.

Source page: https://510kreport.com/device/K972513
Methodology: https://510kreport.com/methodology