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    K Number
    K974611
    Device Name
    MICRO-STRIP FOR AMPHETAMINE METABOLITES
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    1998-03-20

    (99 days)

    Product Code
    DKZ
    Regulation Number
    862.3100
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICRO-STRIP FOR AMPHETAMINE METABOLITES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Microdiagnostics, Inc. Micro-Strip for Amphetamine Metabolites is intended to qualitatively detect the metabolites of Amphetamine and Amphetamine-like drugs in urine.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a government document (FDA approval letter) and does not contain the specific information needed to answer your request regarding acceptance criteria and a study proving device performance. The document confirms that the "Micro-Strip for Amphetamine Metabolites" device is substantially equivalent to legally marketed predicate devices, but it does not detail the performance study, acceptance criteria, or other requested metrics.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number of experts or their qualifications for ground truth.
    4. Adjudication method.
    5. Information on MRMC comparative effectiveness study.
    6. Information on standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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