# K964862: Troponin-I Test System

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Feb 10, 1997 after 68 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
Longest line of descent: 1 generation back to K951890 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951890: Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac Troponin-I Calibrators, Dade Intl., Inc. (1995) Summary page 1.

## Indications for use
to aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Source page: https://510kreport.com/device/K964862
Methodology: https://510kreport.com/methodology