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510(k) Data Aggregation

    K Number
    K972989
    Date Cleared
    1998-01-28

    (169 days)

    Product Code
    Regulation Number
    862.3100
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The STC Methamphetamine Micro-Plate EIA is intended for use in the qualitative determination of methamphetamine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA to STC Technologies, Inc. for their Methamphetamine Micro-Plate EIA device. This type of document confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.

    However, the letter itself does not contain the detailed study results, acceptance criteria, or performance data that would be used to answer your specific questions. It primarily addresses the regulatory status and marketing approval of the device.

    To answer your questions, I would need to review the actual 510(k) submission document or a summary of its contents, which would include the study design, acceptance criteria, and performance data. This information is not present in the provided FDA clearance letter.

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