# K022486: K-Assay HS-CRP Controls

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Aug 14, 2002 after 16 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K061138: Abx Pentra 400 : CRP (2006), 0 descendants of its own

## Indications for use
The K-ASSAY hs-CRP Control Set is intended for use as an assayed quality control material for monitoring the performance of C-Reactive Protein immunoturbidimetric assays.

Source page: https://510kreport.com/device/K022486
Methodology: https://510kreport.com/methodology