# K121603: Randox Immunoassay Speciality Control (II), Level 1, Level 2 and Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Nov 20, 2012 after 228 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: 2 generations back to K891475 (1989). 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)
- K981532: Lyphochek Immunoassay Plus Control, Bio-Rad (1998) Summary page 2.

## Indications for use
The Randox Immunoassay Speciality Control (11) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for Calcitonin, Gastrin, and Procalcitonin to monitor the precision of the laboratory testing systems listed in the package insert. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K121603
Methodology: https://510kreport.com/methodology