# K040379: Randox Immunoassay Control

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jun 16, 2004 after 120 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140522: Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium Plus Tri-Level Control (2014), 0 descendants of its own

## Recalls of this device
- Feb 7, 2019 · Class III · Z-1105-2019: 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 Laboratories Ltd. Immunoassay Controls (Levels 1,11, and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly Immunoassay analysis. The control materials are available at three constituent concentrations, Each level is available in a 5ml final re-constituted volume. The Randox Assayed Immunoassay Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K040379
Methodology: https://510kreport.com/methodology