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510(k) Data Aggregation

    K Number
    K982831
    Device Name
    AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Date Cleared
    1998-11-12

    (93 days)

    Product Code
    JXM
    Regulation Number
    862.3170
    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® Benzodiazepines EIA is intended for use in the Indications I of OSC. The DFC TOTO Cepines in urine. This test is intended for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) summary (K982831/S2 for the AUTO-LYTE® Benzodiazepine EIA) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.

    The document is an FDA clearance letter and an "Indications For Use" statement. It confirms the device's substantial equivalence to a predicate device and its intended use for the qualitative detection of benzodiazepines in urine. However, it does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes used for test and training sets, or data provenance.
    3. Details about experts, ground truth establishment, or adjudication methods.
    4. Information about MRMC studies or standalone algorithm performance.

    To obtain this information, one would typically need to refer to the full 510(k) submission document or a detailed performance study report, which are not included in the provided text.

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