# K130337: Randox Speciality Control (I) Levels 1, 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Jun 19, 2013 after 128 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 K891475 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043108: Liquichek Specialty Immunoassay Control, Bio-Rad Laboratories, Inc. (2004) Summary page 3.

## Indications for use
The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for 1-25 Dihydroxy Vitamin D (1-25 (OH)2 Vitamin D), 25 Hydroxy Vitamin D (25 OH Vitamin D), Anti-Thyroglobulin (Anti TG), Anti-Thyroid Peroxidase (Anti TPO), C-Peptide, Insulin Like Growth Factor (IGF 1), Parathyroid Hormone (PTH), Procalcitonin and Insulin. This device is for prescription use only.

Source page: https://510kreport.com/device/K130337
Methodology: https://510kreport.com/methodology