# K992312: K-Assay CRP (2), K-Assay CRP Multi-Calibrator a, K-Assay CRP Multi-Calibrator B

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Sep 13, 1999 after 66 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Apr 11, 2006 · Not classified · Z-0850-06: Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent

## Indications for use
The K-ASSAY CRP (2) Assay is intended to be used for the quantitative determination of CRP in serum by latex particle enhanced immunoturbidimetric assay. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues. The K-ASSAY CRP Multi-Calibrator A is intended to be used for the calibration of the K-ASSAY CRP (2) Assay. The K-ASSAY CRP Multi-Calibrator B is intended to be used for the calibration of the K-ASSAY CRP (2) Assay.

Source page: https://510kreport.com/device/K992312
Methodology: https://510kreport.com/methodology