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510(k) Data Aggregation

    K Number
    K982759
    Device Name
    AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Date Cleared
    1998-11-20

    (106 days)

    Product Code
    DIO
    Regulation Number
    862.3250
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The STC AUTO-LYTE® Cocaine Metabolite EIA is intended for use in the qualitative determination of benzoylecgonine in urine using a 300 ng/mL cutoff. This test is intended for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "AUTO-LYTE® Cocaine Metabolite EIA." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance).

    The document only states the "Indications For Use" for the device, which is: "The STC AUTO-LYTE® Cocaine Metabolite EIA is intended for use in the qualitative determination of benzoylecgonine in urine using a 300 ng/mL cutoff. This test is intended for in vitro diagnostic use."

    To provide the information you requested, I would need access to the actual 510(k) submission document (K982759) or supporting clinical/technical documentation, which is not available in these provided pages.

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