# K973126: Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Oct 6, 1997 after 47 days
- Product code: JHX (Fluorometric Method, 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.
10 later devices descend from it; 5 cite it directly.
2 of 11 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
- K030286: Triage Cardio Profiler/Triage Cardiac Panel (2003), 3 descendants of its own
- K093758: BGM Galectin -3 (2010), 2 descendants of its own
- K040437: Triage Profiler S.O.B. Panel (2004), 2 descendants of its own
- K140436: ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (2014), 0 descendants of its own
- K111452: Presage ST2 Assay (2011), 0 descendants of its own

## Indications for use
For the quantitative measurement of CK-MB, Myoglobin and Troponin-I in heparinized whole blood. To be used as an aid in the diagnosis of myocardial infarction.

Source page: https://510kreport.com/device/K973126
Methodology: https://510kreport.com/methodology