# K030899: C-Reactive Protein (CRP)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 2, 2003 after 100 days
- Product code: DCN (System, Test, C-Reactive Protein)
- 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 K991385 (1999). 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)
- K991385: Dade Behring N High Sensitivity CRP Assay, Dade Behring, Inc. (1999) Summary page 2.

## Indications for use
The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum or plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K030899
Methodology: https://510kreport.com/methodology