# K111005: Ethanol Reagent, Ethanol Calibrator, Ethanol QC Material

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Nov 15, 2011 after 218 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EasyRA EtOH reagent is intended for the quantitative measurement of Alcohol (EtOH) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. Alcohol measurements are used for the diagnosis and treatment of alcohol intoxication and poisoning. The EasyCal Ethanol Calibrator is intended for in-vitro diagnostic use for the calibration of the ethyl alcohol assay on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine. The EasyQC Ethanol quality control material is intended for in-vitro diagnostic use for the validation of the ethyl alcohol assay, which is used on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine.

Source page: https://510kreport.com/device/K111005
Methodology: https://510kreport.com/methodology