# K112337: Randox Liquid Immunoassay Premium Controls, Level 1, LEVEL2, Level 3 and Tri Level

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Dec 1, 2011 after 108 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Blo-Rad Liquichek Immunoassay Plus Controls Levels 1, 2 and 3: named in the summary without a submission number

## Recalls of this device
- Feb 7, 2019 · Class III · Z-1107-2019: The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

## Indications for use
The Randox Liquid Immunoassay Premium Controls Level 1, Level 2, Level 3 and Tri level are liquid controls developed for use in the quality control of the quantitative assays stated on the package insert. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K112337
Methodology: https://510kreport.com/methodology