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510(k) Data Aggregation

    K Number
    K011952
    Device Name
    DRUGS OF ABUSE MULTI-TEST STRIP
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    2001-10-25

    (126 days)

    Product Code
    DKZ,DIO,DJD,LCM,LDJ
    Regulation Number
    862.3100
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Microdiagnostics, Inc. D&V The Microdiagnostics, Inc. Distincts the metabolit The Microdiagnostics, Inc. barge of detects the metabolites is an immunoassay that quartiallery oceates and Phencyclidine of Amphecamine, Gocaine, Massystems in human urine at the SAMHSA cutoff levels. This test is intended for professional use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a "Multi-Test Strip" device for detecting drugs of abuse in human urine. However, it does not contain any information regarding acceptance criteria, study results, sample sizes (for test or training sets), expert qualifications, ground truth methods, or MRMC studies.

    The document is a letter from the FDA to Microdiagnostics, Inc., confirming the substantial equivalence of their device to legally marketed predicate devices. It lists the device's indications for use and regulatory classifications but does not detail the internal validation studies performed by the manufacturer to establish performance.

    Therefore, I cannot provide the requested information based on the input text.

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