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510(k) Data Aggregation

    K Number
    K102225
    Device Name
    ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
    Manufacturer
    ALCOPRO, INC.
    Date Cleared
    2011-04-06

    (240 days)

    Product Code
    DJZ
    Regulation Number
    862.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALCOPRO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alco-Breath Tube is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. This device provides a semi-quantitative estimate of alcohol levels in breath. The ABT-08 device gives readings between 0 and 0.08% BAC and the ABT-15 device gives readings between 0 and 0.15% BAC. The CheckPoint breath alcohol test is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. The test is available at cut-offs of 0.02, 0.04, 0.05, and 0.08% BAC.
    Device Description
    The Alco-Breath Tube is a disposable, one-time use in vitro diagnostic (IVD) device using a length-of-stain method to give estimates of alcohol concentrations. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The color change is proportional to the concentration of alcohol in the breath. The device provides preliminary screening test results and is not intended to be used as evidential results. The Alco-Breath Tube is intended to detect the presence of alcohol in the breath at concentrations between 0.02 BrAC (Breath Alcohol Concentration) and 0.08 or 0.15 BrAC. The Alco-Breath Tube is intended for screening in medical and therapeutic programs. This product will also give a semi-quantitative estimate of alcohol levels in these ranges. The Alco-Breath Tube is a disposable device designed for one-time use. The CheckPoint® Breath Alcohol Test is a disposable, one-time use in vitro diagnostic (IVD) device using a color change to indicate the presence of alcohol. A chemical reaction occurs when the reagent-treated silica gel is exposed to breath alcohol at or greater than the threshold level of the test device. The results are interpreted based on the observation of a color change within a specified period of test time. The device provides preliminary screening test results and is not intended to be used as evidential results. The CheckPoint® Breath Alcohol Test is intended to detect the presence of alcohol in the breath at a concentration of 0.02% or greater. The CheckPoint® comes in four different alcohol levels: 0.02%. 0.04%. 0.05%. and 0.08%. The alcohol level for each device is printed on the label of the device. The CheckPoint® Breath Alcohol Test are a disposable device designed for one-time use and is intended for screening in medical and therapeutic programs.
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