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510(k) Data Aggregation

    K Number
    K981946
    Device Name
    CLEARVIEW IM
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    1998-12-10

    (190 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CLEARVIEW IM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Clearview™ IM". This document confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

    The letter is a regulatory approval document and not a scientific study report. It states that the device is "an immunoassay for the qualitative detection of Infectious Mononucleosis IgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis."

    Therefore, I cannot provide the requested information based on the text provided. To answer your questions, I would need a different type of document, such as a clinical study report, a scientific publication, or the device's 510(k) submission summary which often includes performance data.

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