# K990704: Array 360 System C-Reactive Protein (CRP Mpe) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 3, 1999 after 60 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
C-Reactive Protein (CRPyre) Reagent, when used in conjunction with Beckman Coulter's Array® 360 System and Calibrator 5 Plus, is intended for the quantitative determination of human C-reactive protein in serum or plasma by rate nephelometry. Clinical Significance: Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.

Source page: https://510kreport.com/device/K990704
Methodology: https://510kreport.com/methodology