# K110904: Randox Liquid Urine Control Levels 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Sep 30, 2011 after 183 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (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 no predicate by number.

## Recalls of this device
- Jun 21, 2023 · Class II · Z-2446-2023: (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error 
- Apr 27, 2017 · Class III · Z-2167-2017: According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments a

## Indications for use
The Randox Liquid Urine Controls Level 2 and Level 3 are liquid controls containing Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumnin, Osmolality, pH, Inorganic Phosphate, Potassium, Total Protein, Sodium, Specific Gravity, Urea and Uric Acid. They have been developed for in vitro diagnostic use in the quality control of Amylase, 'Calciurm, Chloride, Cortisol, Creatininej Glucose, hCG pregnaity; Magniesium, Microalbumnin, Osmolality, pH, Inorganic Phosphate, Potassium, Total Protein, Sodium, Specific Gravity, Urea and Uric Acid assays on various clinical chemistry systems.

Source page: https://510kreport.com/device/K110904
Methodology: https://510kreport.com/methodology