# K092273: Randox Ethanol Assay

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Nov 1, 2010 after 461 days
- Product code: DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method)
- Device class: 2
- Regulation: 21 CFR 862.3040
- Recalls of this device: none
- 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.

## Indications for use
Randox Ethanol Assay The Randox Ethanol Assay is an in vitro diagnostic test for the quantitative analysis of Ethanol in human urine and serum on the"- analysers, which includes the r~daytonar' and the A'hnoir"analysers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning. This is an in vitro diagnostic device intended for prescription use only. Randox Ethanol Calibrator Set The Randox Ethanol Calibrator Set is intended for the calibration of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the A'-. analysers which includes the /k~daytona'"and the AiWr. Randox Ethanol Control Set The Randox Ethanol Control Set is intended for the quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the fl-na analysers which includes the /t'dayton 4 a'" and the fhlfLmci, This is an in vitro diagnostic device intended for prescription use only.

Source page: https://510kreport.com/device/K092273
Methodology: https://510kreport.com/methodology