# K130603: Pathfast CTNL Calibrators

- Pathway: 510(k) (Special)
- Applicant: Mitsubishi Chemical Medience Corporation
- Decided: Mar 27, 2014 after 385 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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.
No later device cites it as a predicate yet.
0 of 5 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 1.

## Indications for use
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/K130603
Methodology: https://510kreport.com/methodology