# K043266: Randox Urine Controls

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Feb 15, 2005 after 81 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- 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
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
- K052242: Advia Chemistry Microalbumin Controls (2005), 0 descendants of its own

## Indications for use
The Randox Laboratories Ltd. Urine Controls are based on lyophilised human urine and have been developed for the control of both accuracy and precision in clinical chemistry applications particularly urine analysis. These control materials are available at two constituent concentrations. The Randox Assayed and Unassayed Urine Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K043266
Methodology: https://510kreport.com/methodology