# K202525: Alinity i STAT High Sensitivity Troponin-I

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories Diagnostics Division
- Decided: May 19, 2022 after 625 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: 9 generations back to K931172 (1993). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191595: ARCHITECT STAT High Sensitivity Troponin-I, Abbott Laboratories Diagnostics Division (2019) Summary page 5.

## Most influential descendants
- K230994: Alinity i STAT High Sensitivity Troponin-I (2023), 0 descendants of its own

## 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 (cTnI) 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 (MI).

Source page: https://510kreport.com/device/K202525
Methodology: https://510kreport.com/methodology