# K992366: Vitros Immunodiagnostic Products Troponin I Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Oct 8, 1999 after 85 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 3.

## Recalls of this device
- Jun 5, 2023 · Class II · Z-2357-2023: Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
- Jun 5, 2023 · Class II · Z-2358-2023: Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

## Indications for use
For the in vitro quantitative measurement of Troponin I (¢Tnl) in human serum or plasma (EDTA or heparin), to aid in the diagnosis of myocardial infarction. For use in the éalibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnl) in human serum and plasma (EDTA or heparin).

Source page: https://510kreport.com/device/K992366
Methodology: https://510kreport.com/methodology