# K981638: Immage Immunochemistry System C-Reactive Protein (CRP) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 12, 1998 after 35 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K860894 (1986). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962523: N Latex CRP Mono Reagent, Behring Diagnostics, Inc. (1996) Summary page 1.

## Most influential descendants
- K050836: CRP Diagnostic Assay (2005), 1 descendant of its own
- K192118: CRP Vario (2019), 0 descendants of its own
- K022690: Paros CRP (2002), 0 descendants of its own
- K990704: Array 360 System C-Reactive Protein (CRP Mpe) Reagent (1999), 0 descendants of its own

## Recalls of this device
- Jan 10, 2008 · Not classified · Z-0921-2010: IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration.

## Indications for use
The IMMAGE Immunochemistry System C-reactive protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.

Source page: https://510kreport.com/device/K981638
Methodology: https://510kreport.com/methodology