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510(k) Data Aggregation

    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
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL

    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.

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