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K Number
K111005
Device Name
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
Manufacturer
MEDICA CORP.
Date Cleared
2011-11-15

(218 days)

Product Code
DIC,DLJ,LAS
Regulation Number
862.3040
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Medica Corporation regarding their Easy RA Ethyl Alcohol Reagent, Calibrator, and QC Material. It details the regulatory approval of the devices for "quantitative measurement of Alcohol (EtOH) in human urine" and states that "Alcohol measurements are used for the diagnosis and treatment of alcohol intoxication and poisoning."

However, this document does not contain information about specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for these devices. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions.

Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text.

§ 862.3040 Alcohol test system.

(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.