# K972408: Cardiac Status Controls

- Pathway: 510(k) (Traditional)
- Applicant: Spectral Diagnostics, Inc.
- Decided: Jul 25, 1997 after 29 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
Cardiac STATus™ Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CKMB/Myoglobin Rapid Test. These external controls complement the monitoring of the test performance by the internal control provided in each test device.

Source page: https://510kreport.com/device/K972408
Methodology: https://510kreport.com/methodology