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510(k) Data Aggregation

    K Number
    K090067
    Device Name
    BACTRACK SELECT BREATHALYZER, MODEL S80
    Manufacturer
    KHN SOLUTIONS, LLC
    Date Cleared
    2009-03-24

    (74 days)

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

    KHN SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
    Device Description
    The BACTRACK® Select Breathalyzer is an alcohol screening device, used for the detection of alcohol in the breath. The BACTRACK® provides a digital result, indicating the approximate BAC (Blood Alcohol Content) of the test subject. The BACTRACK® is powered by two AA batteries and is very easy to use. The device employs a fuel cell sensor of the same type commonly used in evidentiary breathalyzers. This results in generally better accuracy and longer battery life than silicon sensor units. The units are factory calibrated but the product should be recalibrated at least every six to twelve months. If the product is used every day, it may need to be recalibrated as frequently as every month.
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    K Number
    K083801
    Device Name
    BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
    Manufacturer
    KHN SOLUTIONS, LLC
    Date Cleared
    2009-03-19

    (87 days)

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

    KHN SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
    Device Description
    The BACTRACK® Select Breathalyzer is an alcohol screening device, used for the detection of alcohol in the breath. The BACTRACK® provides a digital result, indicating the approximate BAC (Blood Alcohol Content) of the test subject. The BACTRACK® is powered by two AA batteries (two AAA batteries for model S30) and is very easy to use. The device employs a silicon sensor of the same type commonly used in handheld breathalyzers. The units are factory calibrated but the product should be recalibrated at least every six to twelve months. If the product is used every day, it may need to be recalibrated as frequently as every month.
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    K Number
    K071067
    Device Name
    BACTRACK LCD ALCOHOL DETECTOR
    Manufacturer
    KHN SOLUTIONS, LLC
    Date Cleared
    2007-09-14

    (151 days)

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

    KHN SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
    Device Description
    The BACTRACK™ Breathalyzer is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The BACTRACK™ Breathalyzer is has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The BACTRACK™ Breathalyzer sensor uses tin dioxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.
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    K Number
    K041334
    Device Name
    ALCOMATE, MODEL CA2000
    Manufacturer
    KHN SOLUTIONS, LLC
    Date Cleared
    2004-08-11

    (84 days)

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

    KHN SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
    Device Description
    The AlcoMate is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The AlcoMate is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoMate contains a semiconductor oxide sensor designed to test for the presence of alcohol. The AlcoMate semiconductor contains a recently developed ceramic catalytic filter which greatly increases the sensors specificity to alcohol . The AlcoMate sensor uses oxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.
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