# K020662: Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/ Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Apr 12, 2002 after 42 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 K973650 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973650: Troponin (Trop) Method, Dade Chemistry Systems, Inc. (1997) Summary page 2.

## Most influential descendants
- K024193: Modification to Vitros Immundodiagnostic Products Troponin I Reagent Pack/Calibrators (2003), 0 descendants of its own

## 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/K020662
Methodology: https://510kreport.com/methodology