# K231974: PATHFAST®hs-cTnI-II

- Pathway: 510(k) (Traditional)
- Applicant: Phc Corporation
- Decided: Mar 20, 2024 after 261 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: 4 generations back to K981098 (1998). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100130: Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2, Mitsubishi Chemical Medience CO (2011) Summary page 5.

## Most influential descendants
- K240984: i-STAT hs-TnI cartridge with the i-STAT 1 System (2025), 1 descendant of its own
- K253051: i-STAT hs-TnI cartridge with the i-STAT Alinity System (2026), 0 descendants of its own

## Indications for use
PA1HFAST® hs-cTnl-Il is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma. Measurements of cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI). PA1HFAST® hs-cTnl-II is for use in clinical laboratory or point of care (POC) settings.

Source page: https://510kreport.com/device/K231974
Methodology: https://510kreport.com/methodology