# K253051: i-STAT hs-TnI cartridge with the i-STAT Alinity System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Jun 11, 2026 after 262 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: 6 generations back to K981098 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240984: i-STAT hs-TnI cartridge with the i-STAT 1 System, Abbott Point of Care, Inc. (2025) Summary page 5.

## Indications for use
The i-STAT hs-TnI cartridge with the i-STAT Alinity System is intended for use in the in vitro quantification of cardiac troponin I (cTnI) in whole blood or plasma samples in point of care or clinical laboratory settings. The i-STAT hs-TnI cartridge with the i-STAT Alinity System is intended to be used as an aid in the diagnosis of myocardial infarction (MI).

Source page: https://510kreport.com/device/K253051
Methodology: https://510kreport.com/methodology