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510(k) Data Aggregation

    K Number
    K231290
    Device Name
    Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
    Manufacturer
    The Binding Site Ltd.
    Date Cleared
    2024-01-24

    (265 days)

    Product Code
    DFH, DEH
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    The Binding Site Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optilite Freelite Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE), and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings. The Optilite Freelite Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda in serum using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE), and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.
    Device Description
    The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.
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    K Number
    K051299
    Device Name
    IGD DIAGNOSTIC TEST KITS
    Manufacturer
    THE BINDING SITE LTD.
    Date Cleared
    2005-11-23

    (189 days)

    Product Code
    CZJ
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for measuring human Immunoglobulin D (IgD) in serum as an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    Not Found
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