# K132156: Randox CSF Controls Levels 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Oct 23, 2013 after 104 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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: 3 generations back to K871027 (1987). 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)
- K040280: Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls, Roche Diagnostics Corp. (2004) Summary page 2.

## Indications for use
The Randox CSF Controls Levels 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of diagnostic methods using CSF as a sample on clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K132156
Methodology: https://510kreport.com/methodology