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510(k) Data Aggregation

    K Number
    K972032
    Device Name
    VISUALINE II METHAMPHETIMINE
    Manufacturer
    SUN BIOMEDICAL LABORATORIES, INC.
    Date Cleared
    1997-08-12

    (71 days)

    Product Code
    DKZ
    Regulation Number
    862.3100
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    K972037
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Qualitative visual teit for the presence of Methliam phetamine and its metabolites in Uside sample

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Visualine® II Methamphetamine." It states that the device is substantially equivalent to a legally marketed predicate device.

    Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This letter is a regulatory approval document, not a scientific study report.

    Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. To answer your questions, I would need access to the actual 510(k) submission documentation, which would include the study data and performance claims.

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