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510(k) Data Aggregation

    K Number
    K982745
    Device Name
    AUTO-LYTE BARBITURATES EIA
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Date Cleared
    1998-11-18

    (104 days)

    Product Code
    DIS
    Regulation Number
    862.3150
    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® Barbiturates EIA is intended for use in the qualitative determination of barbiturates in urine. This test is intended for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter for the STC AUTO-LYTE® Barbiturates EIA device, dated November 18, 1998. It confirms the device's substantial equivalence to a predicate device and lists its intended use. However, this document does not contain the detailed study information, acceptance criteria, or performance data that you've requested.

    The letter itself is the result of the FDA's review process, which would have involved the manufacturer submitting such studies and data. To answer your questions, I would need access to the actual 510(k) submission document (K982745) that STC Technologies, Inc. sent to the FDA, which is typically not publicly available in this level of detail for older submissions like this one, or the device's labeling which might summarize performance.

    Therefore, based solely on the provided text, I cannot answer your questions.

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