# K022690: Paros CRP

- Pathway: 510(k) (Traditional)
- Applicant: Horiba, Ltd.
- Decided: Dec 23, 2002 after 132 days
- Product code: DCN (System, Test, C-Reactive Protein)
- 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002646: Abx Micros CRP, Abx Diagnostics (2000) Summary page 1.
- K981638: Immage Immunochemistry System C-Reactive Protein (CRP) Reagent, Beckman Coulter, Inc. (1998) Summary page 1.

## Indications for use
The indications for use of the Paros CRP are for aiding in diagnosis and monitoring of inflammatory diseases. The primary utility is for screening for the presence of inflammatory disease, by measuring CRP on anti-coagulated whole blood samples, and thus eliminating the requirement for sample centrifugation. CRP measurement on serum samples is also possible. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein, aids in evaluation of the amount of inflammatory injury to body tissues.

Source page: https://510kreport.com/device/K022690
Methodology: https://510kreport.com/methodology