# K022725: Crpex CRP Controls Level L, M, H; Cat. NO.: 3011, 3012, 3013

- Pathway: 510(k) (Traditional)
- Applicant: Good Biotech Corp.
- Decided: Sep 23, 2002 after 38 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962373 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982087: Roche CRP T Control N, Roche Diagnostic Systems, Inc. (1998) Summary page 1.

## Indications for use
Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K022725
Methodology: https://510kreport.com/methodology