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510(k) Data Aggregation

    K Number
    K172471
    Device Name
    VENTANA CD30 (Ber-H2) RxDx Assay
    Manufacturer
    Ventana Medical Systems, Inc.
    Date Cleared
    2018-05-08

    (266 days)

    Product Code
    DEH
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VENTANA CD30 (Ber-H2) Assay is intended for laboratory use in the qualitative detection of the CD30 protein in formalin-fixed, paraffin-embedded tissue stained with a VENTANA BenchMark ULTRA instrument and OptiView DAB IHC Detection Kit. CD30 positive staining may aid in the identification of classical Hodgkin lymphoma (cHL), anaplastic large cell lymphoma (ALCL) and cutaneous T-cell lymphoma (CTCL). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.
    Device Description
    The VENTANA CD30 (Ber-H2) Assay consists of the primary CD30 (Ber-H2) antibody, detection reagents and an instrument (BenchMark ULTRA automated staining instrument). The VENTANA CD30 (Ber-H2) Assay is a mouse monoclonal antibody (IgG1, kappa) directed against CD30. CD30 antigen is expressed in mononuclear Hodgkin's cells and multinucleated Reed Sternberg cells of Hodgkin Lymphoma as well as on anaplastic large cell lymphomas. This antibody variably produces membranous, cytoplasmic, and Golgi staining of both lymphoma cells and of scattered large activated B and T cells in lymph nodes, spleen, tonsil, and thymus. The OptiView DAB IHC Detection Kit is an indirect, biotin-free system for detecting mouse IgG, mouse IgM, and rabbit primary antibodies. This kit is intended to detect antigens by IHC in sections of formalin-fixed, paraffin-embedded (FFPE) and frozen tissues that are stained on the BenchMark ULTRA instrument (note: the VENTANA CD30 (Ber-H2) Assay will not be recommended for use in frozen tissue). The OptiView DAB IHC Detection Kit produces a visible dark brown precipitate (3, 3'-Diaminobenzidine) via a horseradish peroxidase (HRP) enzymatic reaction at the antigen site. The Pathologist evaluates the brown precipitate using Bright-field microscopy.
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    K Number
    K140396
    Device Name
    FREELITE HUMAN LAMBDA FREE KIT
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2014-04-16

    (57 days)

    Product Code
    DEH
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The kit is intended for the quantitation of lambda free light chains in serum and urine on Binding Site SPAPLUS. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition dissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis and light chain deposition with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K083601
    Device Name
    LAMBDA LIGHT CHAINS
    Manufacturer
    SENTINEL CH. SpA
    Date Cleared
    2009-06-22

    (199 days)

    Product Code
    DEH, JUN
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. Measurement of the different types of light chains aids in the diagnosis of multiple myeloma. Iymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins) and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus in conjunction with other clinical and laboratory findings.
    Device Description
    The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. The determination of Lambda light chains is based on the specific turbidimetric reaction, which occurs between a polyclonal antiserum against human Immunoglobulin Lambda light chains and its corresponding antigen under optimal pH conditions and in the presence of polyethylene glycol (PEG). The turbidity of the immune complex is proportional to the concentration of the analyte in the sample.
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    K Number
    K033811
    Device Name
    FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2004-01-30

    (52 days)

    Product Code
    DEH, DFH
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FREELITE® Human Kappa Free Kit For Use on the Olympus AU analyzer. This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series analysers. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus. FREELITE® Human Lambda Free Kit For Use on the Olympus AU analyzer. This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series analysers. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
    Device Description
    Not Found
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    K Number
    K031016
    Device Name
    FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2003-07-15

    (106 days)

    Product Code
    DEH, DFH
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus. This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.
    Device Description
    Not Found
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    K Number
    K023131
    Device Name
    FREELITE HUMAN LAMBDA FREE KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2003-01-21

    (134 days)

    Product Code
    DEH
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitation of lambda free light chains in serum and urine on the Roche Hitachi 911 and Hitachi 912. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myelomas, lymphocytic neoplasms, Waldenstrom's macroglobulinemia and connective tissue diseases, such as systemic lupus erythematosus.
    Device Description
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    K Number
    K010440
    Device Name
    FREELITE LAMBDA FREE KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2001-04-26

    (72 days)

    Product Code
    DEH
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010441
    Device Name
    FREELITE KAPPA FREE KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2001-04-26

    (72 days)

    Product Code
    DEH
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003671
    Device Name
    LAMBDA IMMAGE FREELITE KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2001-02-01

    (65 days)

    Product Code
    DEH
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002563
    Device Name
    SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2000-10-26

    (70 days)

    Product Code
    DEH
    Regulation Number
    866.5550
    Why did this record match?
    Product Code :

    DEH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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