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510(k) Data Aggregation

    K Number
    K100879
    Device Name
    CONTRALCO
    Manufacturer
    CONTRALCO
    Date Cleared
    2010-08-04

    (127 days)

    Product Code
    DJZ
    Regulation Number
    862.3050
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    Applicant Name (Manufacturer) :

    CONTRALCO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Contralco Alcohol Breath Tester is an in vitro medical device to semi-quantitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs: 0.02, 0.04, 0.05, 0.06, 0.08, and 0.10 relative percent Blood Alcohol Concentration (BAC). The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.
    Device Description
    The Contralco Alcohol Breath Tester is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors. The Tester is made up of 2 parts: the reagent and the plastic bag. One part contains light yellow crystals that change color when exposed to alcohol vapors. The other part (plastic bag) collects the volume of air necessary for the analysis. If alcohol is present, the crystals will change from yellow to light green. The number of crystals that change color will depend on the cut-off of the Tester and the amount of alcohol in the breath. The yellow crystals in the reagent are coated with Chromium VI oxide (CrO3) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cut-off of the tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from yellow to light green when alcohol vapors are present at a level equal to or exceeding the cut-off of the Tester. The Contralco Tester is available in several cut-offs (0.02, 0.04, 0.05, 0.06, 0.08 and 0.10%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.
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