# K252393: VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Oct 29, 2025 after 90 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: 3 generations back to K973517 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062838: Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303, Ortho-Clinical Diagnostics (2006) Summary page 5.

## Indications for use
For In Vitro Diagnostic Use For the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) using the VITROS 5600 Integrated System. Cardiac troponin I is used to aid in the diagnosis of myocardial infarction (MI).

Source page: https://510kreport.com/device/K252393
Methodology: https://510kreport.com/methodology