# K981536: Quantech Myoglobin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hellen Professional Services
- Decided: Jun 29, 1998 after 61 days
- Product code: MVE (Biosensor, Immunoassay, Myoglobin)
- 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 K915850 (1992). 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)
- K915850: Opus Myoglobin Test System, Pb Diagnostic Systems, Inc. (1992) Summary page 2.

## Indications for use
The Quantech Myoglobin Assay is intended to be used as an aid in diagnosing myocardial infarction in patients exhibiting chest pain. It is intended to be used in conjunction with-EKG, and physician examination, as well as possibly other biochemical blood tests to rule in or out non-cardiac damaging origin of the chest pain.

Source page: https://510kreport.com/device/K981536
Methodology: https://510kreport.com/methodology