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510(k) Data Aggregation

    K Number
    K160070
    Device Name
    Rheumatoid Factor (RF) Kit for use on SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2016-12-07

    (329 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Rheumatoid Factor (RF) Kit for use on SPAPLUS

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

    The Rheumatoid Factor (RF) Kit for use on SPAPLUS is intended for the quantitative in vitro measurement of rheumatoid factors in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not contain information about acceptance criteria or specific study details that would allow me to populate the requested table and answer the detailed questions about device performance and study design.

    The document primarily states that the device, "Rheumatoid Factor (RF) Kit For Use On SPAPLUS®," is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements and provides contact information for further inquiries.

    Therefore, I cannot fulfill the request based on the provided text.

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