# K050836: CRP Diagnostic Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Ch. Srl
- Decided: Aug 8, 2005 after 129 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: 3 generations back to K860894 (1986). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030545: CRP-Latex (II)X2 Seiken Assay Kit, Denka Seiken Co., Ltd. (2003) Summary page 3.
- K030546: CRP (II) Calibrators, Denka Seiken Co., Ltd. (2003) Summary page 3.
- K981638: Immage Immunochemistry System C-Reactive Protein (CRP) Reagent, Beckman Coulter, Inc. (1998) Summary page 3.
- K011169: Hscrp Control Level 1, Hscrp Control Level 2, and Hscrp Control Level 3, International Enzymes, Inc. (2001) Summary page 3.

## Most influential descendants
- K192118: CRP Vario (2019), 0 descendants of its own

## Indications for use
CRP Calibrators (CRP Calibrator Set, CRP Calibrator US and CRP Calibrator WR) are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum and EDTA or lithium heparinized plasma samples. CRP Varlo is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. CRP Control US is intended for use as an assayed quality control material for serum C-reactive protein analysis.

Source page: https://510kreport.com/device/K050836
Methodology: https://510kreport.com/methodology