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510(k) Data Aggregation

    K Number
    K172613
    Device Name
    Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
    Manufacturer
    The Binding Site Group Ltd.
    Date Cleared
    2018-02-15

    (168 days)

    Product Code
    PCN, PCO
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    PCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hevylite IgG Kappa kit is a quantitative in vitro assay intended for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum using the Optilite analyser. Measurement of Hevylite IgG Kappa is used alongside Hevylite IgG Lambda to calculate the IgG Lambda ratio. The Hevylite IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG 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 Hevylite IgG Lambda kit is a quantitative in vitro assay intended for the measurement of IgG heavy chain and Lambda light chain intact immunoglobulin) in serum using Site Optilite analyser. Measurement of Hevylite IgG Lambda is used alongside Hevylite IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG 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
    The Hevylite Human IgG Kappa and IgG Lambda Kits contain vials of ready-to-use polyclonal monospecific sheep anti-lgG antisera against combined γ heavy and κ light chain or combined y heavy and À light chain, calibrators (six levels), controls (low and high) and reaction buffer in liquid form. The reagents contain 0.099% sodium azide as preservative.
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    K Number
    K161854
    Device Name
    Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP LTD
    Date Cleared
    2016-10-04

    (90 days)

    Product Code
    PCN, PCO
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    PCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the SPAPLUS analyser for the measurement of IgG kappa (IgG heavy chain and kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma 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 IgG Lambda is a quantitative in vitro assay performed on the SPAPLUS analyser for the measurement of IgG lambda (IgG heavy chain and kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human lgG Lambda is used alongside Hevylite Human IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma 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
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    K Number
    K132555
    Device Name
    HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
    Manufacturer
    THE BINDING SITE
    Date Cleared
    2013-12-20

    (128 days)

    Product Code
    PCN, PCO
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    PCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma 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 IgG Lambda is a quantitative in vitro assay performed on the Siemens BN II nephelometer of IgG Lambda (IgG heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Lambda is used alongside Hevylite Human IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma 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
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