# K062981: I-Chroma CRP Test

- Pathway: 510(k) (Traditional)
- Applicant: Boditech Diagnostics, Inc.
- Decided: Jul 13, 2007 after 287 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
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
The i-CHROMATM CRP test along with i-CHROMA TM Reader is an in vitro diagnostic fluorescence immunoassay that measures C-Reactive Protein in whole blood and serum. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues, infection, and inflammatory disorders.

Source page: https://510kreport.com/device/K062981
Methodology: https://510kreport.com/methodology