# K100130: Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2

- Pathway: 510(k) (Traditional)
- Applicant: Mitsubishi Chemical Medience CO
- Decided: May 16, 2011 after 482 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 K981098 (1998). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033487: Stratus CS Acute Care Troponin I Testpak, Model Cctni, Dade Behring, Inc. (2003) Summary page 8.

## Most influential descendants
- K231974: PATHFAST®hs-cTnI-II (2024), 2 descendants of its own
- 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
- K130603: Pathfast CTNL Calibrators (2014), 0 descendants of its own

## Indications for use
PATHFAST® cTnI-II test is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnI) 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. This method is for use in clinical laboratory or point of care (POC) settings. The PATHFAST® cTnI Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.

Source page: https://510kreport.com/device/K100130
Methodology: https://510kreport.com/methodology