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510(k) Data Aggregation

    K Number
    K250609
    Device Name
    Sober Self-Test
    Manufacturer
    Sober IP LLC
    Date Cleared
    2025-09-15

    (199 days)

    Product Code
    DIC
    Regulation Number
    862.3040
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K121256
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SOBER SELF-TEST is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use.

    Device Description

    Sober Self-Test® strips are a visually read qualitative test for the detection of alcohol concentration in saliva. It consists of a visually interpreted test strip that develops a distinct blue color on the test pad when wet with human saliva that has a Alcohol Concentration (AC) equal to or greater than 0.02%. The device consists of a single test in a foil packet or in boxes of three, six, twelve, or 24 boxes of single test packets, each designed for one-time use only.

    AI/ML Overview

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