# K062751: Modification to Quantimetrix Cardiasure Cardiac Marker

- Pathway: 510(k) (Special)
- Applicant: Quantimetrix Corp.
- Decided: Oct 3, 2006 after 19 days
- Product code: JJT (Enzyme Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

Source page: https://510kreport.com/device/K062751
Methodology: https://510kreport.com/methodology