# K052591: Nanopia Wide Range C-Reactive Protein (CRP) Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Data, Inc.
- Decided: Feb 9, 2006 after 141 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: 1 generation back to K040241 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040241: N-Geneous Wide Range CRP Reagent and Calibrator Set, Genzyme Corp. (2004) Summary page 2.

## Indications for use
The Nanopia Wide Range CRP Reagent is intended for the quantitative measurement of C-Reactive Protein (CRP) in serum or plasma. The assay is intended for use in the evaluation of infection, tissue injury, and inflammatory disorders in combination with a complete clinical evaluation.

Source page: https://510kreport.com/device/K052591
Methodology: https://510kreport.com/methodology