# K230994: Alinity i STAT High Sensitivity Troponin-I

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories Diagnostics Division
- Decided: May 4, 2023 after 27 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: 10 generations back to K931172 (1993). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202525: Alinity i STAT High Sensitivity Troponin-I, Abbott Laboratories Diagnostics Division (2022) Summary page 5.

## Indications for use
The Alinity i STAT High Sensitivity Troponin-I assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of cardiac troponin I (cTnl) in human plasma (lithium heparin) on the Alinity i system. The Alinity i STAT High Sensitivity Troponin-I assay is to be used as an aid in the diagnosis of myocardial infarction (MD).

Source page: https://510kreport.com/device/K230994
Methodology: https://510kreport.com/methodology