# K013787: Nycocard CRP

- Pathway: 510(k) (Traditional)
- Applicant: Primus Corp.
- Decided: May 14, 2002 after 181 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
NycoCard® CRP Test system is an in vitro diagnostic device for the quantification of C-reactive protein (CRP) in human serum, plasma, and whole blood by a solid phase, sandwich-format, immunometric assay. The measurement of CRP aids in evaluation of the acute inflammatory process induced by infectious microbial agents or by non-infectious inflammatory stimuli.

Source page: https://510kreport.com/device/K013787
Methodology: https://510kreport.com/methodology