# K040030: Biocheck Cardiac-1 CRP Rapid Test, Model BC-804114

- Pathway: 510(k) (Traditional)
- Applicant: Biocheck, Inc.
- Decided: Jun 16, 2004 after 161 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. The FDA summary names its predicate without a number.
- (no number) BioCheck hsCRPforELISA: named in the summary without a submission number

## Indications for use
The BioCheck CRP Rapid Test is intended for the qualitative detection of C-reactive protein (CRP) in human serum. Measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Source page: https://510kreport.com/device/K040030
Methodology: https://510kreport.com/methodology