# K130628: Pathfast CK-MB-II Calibrators

- Pathway: 510(k) (Special)
- Applicant: Mitsubishi Chemical Medience Corporation
- Decided: Oct 4, 2013 after 210 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: 1 generation back to K081360 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081360: Pathfast CK-MB-II, Pathfast Myo-II, Mitsubishi Kagaku Iatron (2009) Summary page 2.

## Indications for use
The PATHFAST CK-MB-II Calibrators are for calibration of the PATHFAST system when used for the quantitative determination of creatine kinase-MB in human heparinized or EDTA whole blood and plasma.

Source page: https://510kreport.com/device/K130628
Methodology: https://510kreport.com/methodology