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510(k) Data Aggregation

    K Number
    K972456
    Device Name
    RHEUMACOL RHEUMATOID FACTOR TEST
    Manufacturer
    IMMUNOSTICS, INC.
    Date Cleared
    1997-11-25

    (147 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Rheumacol RF Test is a rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor (RF) in serum. This test is used as an aid in the diagnosis of rheumatoid arthritis. This test is "For Professional Use Only".

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "Rheumacol RF Test". This document confirms that the device has been found substantially equivalent to a legally marketed predicate device. However, it does not contain any information about the acceptance criteria, reported device performance, study design, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report or a 510(k) summary.

    Therefore, I cannot provide the requested information from the given text.

    To answer your questions, I would need access to the actual 510(k) submission document (K972456 summary) which details the studies performed to demonstrate substantial equivalence. The provided document is only the FDA's clearance letter.

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