# K071002: Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 21, 2007 after 73 days
- Product code: NQD (Cardiac 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: 2 generations back to K991385 (1999). 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)
- K033908: N High Sensitivity CRP, Dade Behring, Inc. (2004) Summary page 1.
- K010236: Immage Immunochemistry System High Sensitivity C-Reactive Protein (CRPH) Reagent, Beckman Coulter, Inc. (2001) Summary page 1.
- K926236: Beckman Anti-Streptolysin O Kit, Beckman Instruments, Inc. (1993) Summary page 1.

## Indications for use
High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent, when used in conjunction with IMMAGE® 800 Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry. Clinical Significance: Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used inconjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome. CAL 5 Plus (Calibrator 5 Plus), when used in conjunction with Beckman Coulter reagents, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin 0 (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).

Source page: https://510kreport.com/device/K071002
Methodology: https://510kreport.com/methodology