# K110846: Randox Urinalysis Controls, Levels 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Sep 30, 2011 after 186 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jul 25, 2019 · Class III · Z-2557-2019: Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.

## Indications for use
The Randox Urinalysis Controls (URNAL Control 1 and URNAL Control 2 ) are urine controls containing Bilirubin, Blood, Creatinine, Crystals, Galactose, Glucose, hCG, Ketones, Leukocytes, Microalbumin, Nitrite, pH, Protein, Red Blood Cells, Specific Gravity, Urobilinogen and White Blood Cells. The Randox Urinalysis controls (URNAL Control 1 and URNAL Control 2 ) are intended for in vitro diagnostic use in the quality control of urine test strips for the analytes; Bilirubin, Blood, Creatinine, Glucose, Ketones, Leukocytes, Microalbumin, Nitrite, pH, Protein, Specific Gravity and Urobilinogen. This control is also intended for the evaluation of microscopic test procedures for Crystals, Red Blood Cells and White Blood Cells and also for the confirmatory tests hCG and Galactose. This in vitro diagnostic device is intended for prescription use only

Source page: https://510kreport.com/device/K110846
Methodology: https://510kreport.com/methodology