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510(k) Data Aggregation

    K Number
    K090766
    Device Name
    LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
    Manufacturer
    LIFELOC TECHNOLOGIES, INC.
    Date Cleared
    2009-07-23

    (122 days)

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

    LIFELOC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeGuard and BacTrack B90 devices are intended to measure alcohol in human breath. Measurements obtained from these devices are used in the diagnosis of alcohol intoxication. The LifeGuard and BacTrack B90 devices are intended to be used by the general adult population and by qualified personnel, such as physicians, nurses, and technicians. The LifeGuard and BacTrack B90 devices are intended to be used by adults (age 21 and over) in measuring alcohol intoxication in themselves or others. The LifeGuard and BacTrack B90 devices are intended to be used in both home (over-the-counter) and clinical settings.
    Device Description
    The LifeGuard product is a breath alcohol detector designed to sample the patient's deep lung air in order to test for the presence of alcohol in the blood. The sensor used in the LifeGuard is an electrochemical fuel cell sensor. When the patient exhales into the device, after 4 seconds a sample of the breath is pumped into the fuel cell and generates an electrical current. The amount and duration of the current has a known relationship to the concentration of alcohol in the breath sample. The relationship between the alcohol concentration in the deep lung breath and in the blood is known by Henry's law with a ratio of 2100:1. The BacTrack B90 has the same intended use, description and performance characteristics as the LifeGuard with a different physical appearance. Both the LifeGuard and BacTrack B90 products are handheld and are used with a single-use disposable mouthpiece and a replaceable 9 volt battery.
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