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510(k) Data Aggregation

    K Number
    K013538
    Device Name
    ETHANOL
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    2001-12-14

    (51 days)

    Product Code
    DML
    Regulation Number
    862.3040
    Why did this record match?
    Product Code :

    DML

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The Ethanol assay should be exclusively used to detect ethanol and not other alcohols such as isopropanol or methanol. Reactivity with compounds structurally unrelated to ethanol has not been observed.
    Device Description
    Ethanol is an in vitro diagnostic assay for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The assay is based on an enzymatic reaction. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically. The increase in absorbance at 340 nm is proportional to the concentration of alcohol in the specimen.
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    K Number
    K993980
    Device Name
    SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
    Manufacturer
    SYVA CO.
    Date Cleared
    2000-02-01

    (69 days)

    Product Code
    DML
    Regulation Number
    862.3040
    Why did this record match?
    Product Code :

    DML

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human serum or plasma. The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human urine, plasma, and serum. The Emit® II Plus Ethyl Alcohol Assay is designed for use with most clinical chemistry analyzers.
    Device Description
    The Syva Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in quantitative analysis of ethyl alcohol in human urine, serum, or plasma.
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    K Number
    K963197
    Device Name
    ON.SITE ALCOHOL
    Manufacturer
    ANSYS, INC.
    Date Cleared
    1996-09-19

    (35 days)

    Product Code
    DML
    Regulation Number
    862.3040
    Why did this record match?
    Product Code :

    DML

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ON•SITE Alcohol is recommended for professional use only and is not intended for overthe-counter sale to the general public. Professional use includes applications in healthcare, corrections and drug treatment. ON•SITE Alcohol yields only a "qualitative" result. A positive result indicates that alcohol (ethanol) is present at a concentration of approximately 0.02% when performed according to the instructions. Confirmation of ON•SITE Alcohol results using gas chromatography is recommended if quantitative results are desired.
    Device Description
    ON•SITE Alcohol is a self contained, disposable enzymatic test device that provides rapid detection of alcohol in saliva or urine. It includes all reagents and supplies necessary to perform the test.
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