# K121588: Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jun 20, 2012 after 20 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 K953239 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041627: Cystatin C Immunoparticles, Control Set, Calibrator, Dako A/S (2004) Summary page 1.

## Indications for use
The Randox Cystatin C Controls Level 2 and Level 3 are intended for use as assayed quality control material for monitoring the precision and accuracy of the quantitative determination of human Cystatin C by immunoturbidimetric Assays. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Source page: https://510kreport.com/device/K121588
Methodology: https://510kreport.com/methodology