# K242170: K-ASSAY CRP (Ver.2)

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Company, LLC
- Decided: Apr 18, 2025 after 268 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- 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
Longest line of descent: 1 generation back to K023828 (2003). 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)
- K023828: K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP Multi-Calibrator E, K-Assay CRP Multi-Calibr, Kamiya Biomedical Co. (2003) Summary page 5.

## Indications for use
K-ASSAY CRP (Ver.2) is intended to be used for the quantitative determination of C-reactive protein (CRP) in human serum and plasma (potassium-EDTA or lithium-heparin) by immunoturbidimetric assay. Measurement of CRP aids in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K242170
Methodology: https://510kreport.com/methodology