# K024193: Modification to Vitros Immundodiagnostic Products Troponin I Reagent Pack/Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Feb 21, 2003 after 63 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: 2 generations back to K973650 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020662: Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/ Calibrators, Ortho-Clinical Diagnostics (2002) Summary page 1.

## Indications for use
For the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction. For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human heparin plasma.

Source page: https://510kreport.com/device/K024193
Methodology: https://510kreport.com/methodology