# K972094: Target Cardiac Troponin I Test

- Pathway: 510(k) (Traditional)
- Applicant: Texas Immunology, Inc.
- Decided: Jul 23, 1997 after 49 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.
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
A rapid enzyme immunoassay test for the quantitative detection of cardiac troponin-I in serum and heparinized plasma as an aid in the diagnosis of acute myocardial infarction. This test is to be used in clinical and hospital laboratories and is not for Doctor's offices use.

Source page: https://510kreport.com/device/K972094
Methodology: https://510kreport.com/methodology