# K021194: Raichem CRP High Sensitivity Test System

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Jul 29, 2002 after 105 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.
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.

## Indications for use
Reagent: This reagent is intended for the quantitative in vitro measurements of C-reactive protein (CRP) in human serum or heparin and EDTA plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. Calibrator: The Raichem C-reactive Protein (CRP) Serum Calibrators are prepared from pooled human serum with added CRP purified from human pleural fluid, and are for use as calibrators in the measurement of CRP by latex turbidimetric immunoassays. Preservatives and stabilizers have been added.

Source page: https://510kreport.com/device/K021194
Methodology: https://510kreport.com/methodology