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510(k) Data Aggregation

    K Number
    K011813
    Device Name
    AMEDITECH IMMUTEST DRUG SCREEN THC
    Manufacturer
    AMEDITECH, INC.
    Date Cleared
    2001-10-22

    (133 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ameditech ImmuTest™ Drug Screen THC is an In Vitro screen test for the presence of 11-nor-Δ'-THC-9-carboxylic acid (THC) in human urine at cut-off concentration of 50 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Ameditech ImmuTest™ Drug Screen THC" device. It does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on the FDA's substantial equivalence determination for marketing the device.

    Therefore, I cannot fulfill the request to provide the acceptance criteria and the study that proves the device meets them based on this document.

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