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510(k) Data Aggregation

    K Number
    K012585
    Device Name
    AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
    Manufacturer
    AMEDITECH, INC.
    Date Cleared
    2001-11-16

    (98 days)

    Product Code
    LAF
    Regulation Number
    862.3610
    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 METHAMPHETAMINE is an In Vitro screen test for the qualitative detection of Methamphetamine in human urine at cut-off concentration of 500 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 is a 510(k) clearance letter from the FDA for the "Ameditech ImmuTest™ Drug Screen METHAMPHETAMINE." This document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/device performance study.

    The document is a legal notification that the device has been found substantially equivalent to a predicate device and can be marketed. It defines the device name, regulation number, regulatory class, and product code, along with its indications for use (qualitative detection of Methamphetamine in human urine at a cut-off concentration of 500 ng/ml).

    Therefore, I cannot fulfill your request with the input provided.

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