# K992311: K-Assay CRP (1), K-Assay CRP Multi-Calibrator a, K-Assay CRP Multi-Calibratorc

- 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: 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
- K021757: Crpex-BR C-Reactive Protein Lit Assay, Crpex-BR CRP Calibrator Set (2002), 0 descendants of its own

## Indications for use
The K-ASSAY CRP (I) Assay is intended to be used for the quantitative determination of - C-Reactive Protein (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 (l) Assay. The K-ASSAY CRP Multi-Calibrator C is intended to be used for the calibration of the K-ASSAY CRP (l) Assay.

Source page: https://510kreport.com/device/K992311
Methodology: https://510kreport.com/methodology