# K030057: Spectral Cardiac Status CK-MB/Myoglobin/Troponin I 3-in-1 Test

- Pathway: 510(k) (Traditional)
- Applicant: Spectral Diagnostics, Inc.
- Decided: Mar 19, 2003 after 71 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K050975: Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase MB and Myoglobin (2006), 0 descendants of its own

## Indications for use
For the qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.

Source page: https://510kreport.com/device/K030057
Methodology: https://510kreport.com/methodology