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510(k) Data Aggregation

    K Number
    K061970
    Device Name
    ELECSYS IGE II IMMUNOASSAY
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2006-08-31

    (50 days)

    Product Code
    JHR
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    JHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the in vitro quantitative determination of immunoglobulin E in human serum and plasma. Determination of total IgE is useful as an aid in the diagnosis of allergic diseases. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
    Device Description
    The Elecsys IgE II immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
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    K Number
    K984326
    Device Name
    ELECYS IGE ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1999-02-08

    (67 days)

    Product Code
    JHR
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    JHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Determination of total serum IgE is useful as an aid in the diagnosis of allergic disease.
    Device Description
    The Elecsys® IgE test is based on the sandwich principle of heterogeneous immunological complex formation. First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled antibodies (R2), both specific for IgE, bind IgE present in the sample forming a sandwich complex Second Step: Microparticles coated with streptavidin (M) bind the biotin portion of the complex and are captured magnetically onto the surface of the electrode. Application of a voltage to the electrode induces chemiluminescent emission, which is measured by a photomultiplier.
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    K Number
    K960067
    Device Name
    IMMILITE TOTAL IGE
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    1996-02-14

    (40 days)

    Product Code
    JHR
    Regulation Number
    866.5510
    Why did this record match?
    Product Code :

    JHR

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