# K984433: Quantech CK-MB Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quantech, Ltd.
- Decided: Nov 1, 1999 after 322 days
- Product code: MYT (Biosensor, Immunoassay, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- 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) AxSYM CK-MB assay: named in the summary without a submission number

## Indications for use
The Quantech CK-MB Assay is intended to be used for the quantitative determination of the cardiac isoenzyme CK-MB, in order to assist in the diagnosis of acute myocardial infarction.

Source page: https://510kreport.com/device/K984433
Methodology: https://510kreport.com/methodology