# K021757: Crpex-BR C-Reactive Protein Lit Assay, Crpex-BR CRP Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Good Biotech Corp.
- Decided: Jul 29, 2002 after 61 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 K992311 (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)
- K992311: K-Assay CRP (1), K-Assay CRP Multi-Calibrator a, K-Assay CRP Multi-Calibratorc, Kamiya Biomedical Co. (1999)

## Indications for use
Good Biotech Cop. CRPex-BR C-reactive protein LIT assay is intended to be used for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. Good Biotech Cop. CRE'ex-BR CRJ? calibrator set is intended to be used with CRPex-BR C-reactive protein LIT assay for the quantitative determination of C-reactive protein in serum samples.

Source page: https://510kreport.com/device/K021757
Methodology: https://510kreport.com/methodology