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510(k) Data Aggregation

    K Number
    K023592
    Device Name
    SERAQUEST ANTI-THYROGLOBULIN
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    2003-01-06

    (73 days)

    Product Code
    DDC
    Regulation Number
    866.5870
    Why did this record match?
    Product Code :

    DDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. For the quantitative detection of IqG antibodies to thyroglobulin in human serum by enzyme immunoassay. 2. The SeraQuest Anti-thyroglobulin test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease. 3. For in vitro diagnostic use only.
    Device Description
    The SeraQuest Anti-Thyroglobulin test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IqG antibodies which are directed against thyroglobulin, in human serum. The Calibrators in the SeraQuest Anti-Thyroglobulin test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).
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    K Number
    K012208
    Device Name
    ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2001-09-07

    (53 days)

    Product Code
    DDC
    Regulation Number
    866.5870
    Why did this record match?
    Product Code :

    DDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access® Thyroglobulin Antibody (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access® Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.
    Device Description
    The Access Thyroglobulin Antibody reagents, Thyroglobulin Antibody calibrators, and the Access Immunoassay Analyzer comprise the Access Immunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
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    K Number
    K000363
    Device Name
    MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    2000-02-18

    (14 days)

    Product Code
    DDC
    Regulation Number
    866.5870
    Why did this record match?
    Product Code :

    DDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991610
    Device Name
    ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1999-06-25

    (46 days)

    Product Code
    DDC
    Regulation Number
    866.5870
    Why did this record match?
    Product Code :

    DDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zeus Scientific, Inc. TPO (thyroid peroxidase) IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semiquantitative detection of IgG autoantibodies to human thyroid peroxidase in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.
    Device Description
    Not Found
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    K Number
    K991179
    Device Name
    ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1999-06-17

    (71 days)

    Product Code
    DDC
    Regulation Number
    866.5870
    Why did this record match?
    Product Code :

    DDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zeus Scientific, Inc. Thyroglobulin IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgG autoantibodies to human thyroglobulin in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.
    Device Description
    Not Found
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    K Number
    K971835
    Device Name
    ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
    Manufacturer
    MONOBIND
    Date Cleared
    1997-07-03

    (45 days)

    Product Code
    DDC
    Regulation Number
    866.5870
    Why did this record match?
    Product Code :

    DDC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The quantitative determination of thyroglobulin autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter.
    Device Description
    The Monobind method is based on ELISA technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing blotinylated thyroglobulin antigen, and a serum containing the autoantibody (anti-Tg), reaction results between the biotinylated thyroglobulin antigen and the antibodies to form an immune complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin, coated on the well, and biotinylated thyroglobulin antigen. After incubation is complete, decantation or aspiration separates the unbound components. The enzyme linked species specific antibody (anti-h-igG) is then added to the microwells. The anti-h-lgG enzyme conjugate that binds to the immobilized immune complex in a second incubation are separated from unreacted material by a wash step. The enzyme activity in this fraction Is directly proportional to the antibody concentration in the specimen. By utilizing several different serum references of known antibody activity, a reference curve can be generated from which the antibody activity of an unknown can be ascertained.
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