# K031031: Vitros Immunodiagnostic Products Troponin I Reagent Pack and Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Sep 29, 2003 after 181 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 2 (0 Class I)
- 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.
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)
- K973650: Troponin (Trop) Method, Dade Chemistry Systems, Inc. (1997) Summary page 2.

## Recalls of this device
- Apr 27, 2007 · Not classified · Z-0820-2007: Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.
- Jun 7, 2004 · Not classified · Z-1053-04: Random occurrence of false positive test results.

## 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 hepan

Source page: https://510kreport.com/device/K031031
Methodology: https://510kreport.com/methodology