# K023828: K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP Multi-Calibrator E, K-Assay CRP Multi-Calibr

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Feb 4, 2003 after 78 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K242170: K-ASSAY CRP (Ver.2) (2025), 0 descendants of its own
- K061138: Abx Pentra 400 : CRP (2006), 0 descendants of its own
- K050713: Duet HS-CRP Lit Assay, Catalog Number:  4010, Duet HS-CRP Calibrator Set, Catalog Number: 4511 (2005), 0 descendants of its own

## Recalls of this device
- May 1, 2009 · Not classified · Z-0973-2010: The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.

## Indications for use
The K-ASSAY @ CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases. The K-ASSAY CRP Multi-Calibrator D is intended to be used for the calibration of the K-ASSAY CRP (3) Assay. The K-ASSAY CRP Multi-Calibrator E is intended to be used for the calibration of the K-ASSAY @ CRP (3) Assay. The K-ASSAY CRP Multi-Calibrator F is intended to be used for the calibration of the K-ASSAY @ CRP (3) Assay.

Source page: https://510kreport.com/device/K023828
Methodology: https://510kreport.com/methodology