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510(k) Data Aggregation

    K Number
    K981314
    Device Name
    VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
    Manufacturer
    SUN BIOMEDICAL LABORATORIES, INC.
    Date Cleared
    1998-09-04

    (147 days)

    Product Code
    DJR
    Regulation Number
    862.3620
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Qualitative visual test for the presence of Methadone and its metabolites in urine samples.

    Device Description

    Visualine II (Also Known As SunLine) Methadone

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the Visualine II (SunLine) Methadone device does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

    This document is a marketing clearance letter, which states that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to a legally marketed predicate device for the stated indications for use. It outlines regulatory classifications, general controls, and contact information for further inquiries.

    To answer your request, I would need to analyze a different type of document, such as the actual 510(k) summary, a clinical study report, or a validation report, which would typically contain details about performance studies and acceptance criteria.

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