# K022682: Randox C-Reactive Protein Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Nov 5, 2002 after 85 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K081294: Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), Calibrators (2008), 0 descendants of its own
- K072658: Advia Chemistry C-Reactive Protein_2, (CRP_2) and Calibrators (2008), 0 descendants of its own

## Indications for use
The Randox Laboratories Limited C-Reactive Protein Calibrators are liquid calibrators containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the calibration of CRP assays. The constituent concentrations of the Randox Laboratories Limited C-Reactive Protein Calibrator are present at 6 levels. The Randox Laboratories Limited C-Reactive Protein Calibrators should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K022682
Methodology: https://510kreport.com/methodology