# K091052: Piccolo C-Reactive Protein (CRP) Test System

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Jan 15, 2010 after 277 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: 3 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)
- K070626: Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent, Beckman Coulter, Inc. (2007) Summary page 1.

## Indications for use
C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction With other laboratory and clinical finidings.

Source page: https://510kreport.com/device/K091052
Methodology: https://510kreport.com/methodology