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510(k) Data Aggregation

    K Number
    K990462
    Device Name
    IS H. PYLORI IGG ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1999-09-03

    (203 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the qualitative determination of IgG antibodies to Helicobactor pylori antigen in human sera by indirect enzyme immunoasay. The H.pylori IgG assay may be used as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test can be performed either manually or in conjunction with the MAGO® PLUS Automated EIA Processor.
    Device Description
    The & H. pylori IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to H. pylori antigen in human serum.
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    K Number
    K991274
    Device Name
    MUMPS IGG ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1999-09-03

    (143 days)

    Product Code
    LJY
    Regulation Number
    866.3380
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the qualitative and semi-quantitative determination of IgGi antibodies to Mumps virus m human serum of adults over cighteen vears of age by indirect enzyme immunoassay as an aid in the diaunosis at Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antihody itel can also aid in the diagnosis of acute infection by seroconversion through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated EIA processor. Performance characteristics have not been established on children
    Device Description
    The & Mumps IgG ELISA Kit is an Enzyme-Linked ImmunoSorbent Assay (E.I.S.A) (6) the detection of IgG antibodies to Mumps antigen in human serum.
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    K Number
    K984228
    Device Name
    IS ANTI-TPO IGG ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1999-02-02

    (69 days)

    Product Code
    JZO
    Regulation Number
    866.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TPO IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative detection and quantitation of antibodies against the thyroid peroxidase antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.
    Device Description
    The & TPO IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to thyroid peroxidase in human serum.
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    K Number
    K983605
    Device Name
    IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1998-12-16

    (63 days)

    Product Code
    LSR
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.
    Device Description
    The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum.
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    K Number
    K983606
    Device Name
    IS BORRELIA BURGDORFERI IGM TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1998-12-16

    (63 days)

    Product Code
    LSR
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor. The Is-anti-Borrelia burgdorferi IgM Test Kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to develop IgG antibodies. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.
    Device Description
    The & Borrelia burgdorferi IgM ELISA Kit is an enzyme-finked immunosorbent assay (ELISA) for the detection of IgM to Borrelia burgdorferi antigen in human serum.
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    K Number
    K983553
    Device Name
    ANTI-TG IGG ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1998-12-07

    (59 days)

    Product Code
    JZO
    Regulation Number
    866.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TG IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection and quantitation of antibodies against the Thyroglobulin (TG) antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed either manually or in conjunction with the Mago Plus automated ETA processor.
    Device Description
    The TG IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Thyroglobulin in human serum.
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    K Number
    K982348
    Device Name
    EBNA-1 IGM ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1998-11-25

    (142 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the qualitative determination of IgM antibodies in human serum to Epsien Barr Virus (recombinant) Nuclear antigen (EBNA-1) antigen. The 78 EBNA-1 IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS TM Automated EIA Processor.
    Device Description
    The & EBNA-1 IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Nuclear antigen-1 in human serum.
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    K Number
    K982350
    Device Name
    EA-D IGM ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1998-11-25

    (142 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the qualitative determination of IgM antibodies in human serum to Epstein Barr (recombinant) early antigen diffuse (EA-D) antigen. The & EA-D IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EBNA-1 IgG, EBNA-1 IgM, EA-D IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS The Automated EIA Processor.
    Device Description
    The & EA-D IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Early antigen diffuse in human serum.
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    K Number
    K982352
    Device Name
    VCA IGM ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1998-11-25

    (142 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the qualitative determination of IgM antibodies in human serum to Epstein Barr (recombinant) Viral Capsid antigen (EBV-VCA) antigen. The EBV-VCA IgM assay should be used in conjunction with other Epstein-Barr serologies (EBV-VCA IgG, EBNA-1 IgG, EA-D IgG, EA-D IgM, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious monomucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS ™ Automated EIA Processor.
    Device Description
    The & EBV-VCA IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Viral Capsid antigen in human serum.
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    K Number
    K983390
    Device Name
    IS-ANTI-MPO IGG ELISA TEST SYSTEM
    Manufacturer
    COLUMBIA BIOSCIENCE, INC.
    Date Cleared
    1998-11-18

    (54 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLUMBIA BIOSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The & MPO IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative detection and semi-quantitation of antibodies against the Myeloperoxidase antigen in serum as an aid in the diagnosis of Microscopic polyangiitis. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.
    Device Description
    The & MPO IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Myeloperoxidase in human serum.
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