# K083412: Pathfast Hscrp

- Pathway: 510(k) (Traditional)
- Applicant: Mitsubishi Kagaku Iatron
- Decided: Mar 9, 2009 after 111 days
- Product code: DCN (System, Test, C-Reactive Protein)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
PATHFAST® hsCRP test, for use with PATHFAST® analyzer, is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in heparinized or EDTA whole blood, plasma, and serum, as an aid in the detection and evaluation of the infection, tissue injury, inflammatory disorders, and associated disorders. This method is for use in clinical laboratory or point of care (POC) settings. PATHFAST® hsCRP Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the PATH FAST® System.

Source page: https://510kreport.com/device/K083412
Methodology: https://510kreport.com/methodology