# K040351: Randox Liquid CRP Controls

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Mar 12, 2004 after 29 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
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 Randox Laboratories Ltd. C-Reactive Protein Controls are liquid controls containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The control materials are available at two constituent concentrations. The Randox Liquid C-Reactive Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K040351
Methodology: https://510kreport.com/methodology