Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K160819
    Device Name
    Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
    Manufacturer
    THE BINDING SITE GROUP LTD.
    Date Cleared
    2016-06-16

    (84 days)

    Product Code
    OPX, OPY
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    OPX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments. The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Lambda is used alongside Hevylite IgA Kappa to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
    Device Description
    Not Found
    Ask a Question
    K Number
    K151759
    Device Name
    Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP LTD.
    Date Cleared
    2015-11-06

    (130 days)

    Product Code
    OPX, OPY
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    OPX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Binding Site SPAPLUS for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments. Hevylite Human IgA Lambda is a quantitative in vitro assay performed on The Binding Site SPAPLUS for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
    Device Description
    Not Found
    Ask a Question
    K Number
    K140105
    Device Name
    HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
    Manufacturer
    THE BINDING SITE
    Date Cleared
    2014-03-18

    (62 days)

    Product Code
    OPX, OPY
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    OPX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the JgA Kappa / IgA I levylite I luman IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple mycloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunotixation. bone marrow and urine assessments. Hevylite Human IgA Lambda is a quantiative in vitro assy performed on the Siemens IN II nepheloment of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in scrum. Mcasurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Lamburratio. The Hevylite Human IgA Kappa / 12A Lambda ratio can be used when monitoring previously diagnosed lgA multiple mycloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1