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    K Number
    K162263
    Device Name
    Optilite Rheumatoid Factor Kit
    Manufacturer
    THE BINDING SITE GROUP LTD.
    Date Cleared
    2017-05-03

    (265 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K972220,K160070
    Why did this record match?
    Reference Devices :

    K972220

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

    The Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite 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

    The Optilite Rheumatoid Factor Kit comprises the following reagents: Reaction Buffer, Latex Reagent, RF Controls (supplied at 2 levels, Low and High), and RF Calibrator.

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    1. Table of Acceptance Criteria and the Reported Device Performance

    Performance CharacteristicAcceptance CriteriaReported Device Performance
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