# K982679: Multiquant (R) Quantitative Myoglobin Test

- Pathway: 510(k) (Traditional)
- Applicant: Spectral Diagnostics, Inc.
- Decided: Oct 7, 1998 after 68 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dade-Behring Stratus® Myoglobin Fluorometric Assay: named in the summary without a submission number

## Indications for use
The Multiquant® Quantitative Myoglobin Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the myoglobin ( an oxygen storage protein found in muscle) in serum and plasma. Measurement of myoglobin aids in the rapid diagnosis of heart disease.

Source page: https://510kreport.com/device/K982679
Methodology: https://510kreport.com/methodology