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    K Number
    K110274
    Device Name
    AUTODELFIA NEONATAL IRT KIT
    Manufacturer
    WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
    Date Cleared
    2011-06-10

    (130 days)

    Product Code
    JNO, PRE
    Regulation Number
    862.1725
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.
    Device Description
    The AutoDELFIA Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls and test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from the dried blood on filter paper disks. The complete assay requires only one incubation step. Enhancement Solution dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.
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    K Number
    K102419
    Device Name
    GSP NEONATAL IRT KIT (3306-001U)
    Manufacturer
    WALLAC OY, SUBSIDIARY OF PERKINELMER
    Date Cleared
    2010-12-16

    (113 days)

    Product Code
    JNO
    Regulation Number
    862.1725
    Why did this record match?
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    Matched: '862.1725'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GSP Neonatal IRT kit is intended for the quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument.
    Device Description
    The GSP Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls or test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from dried blood on filter paper disks. The complete assay requires only one incubation step. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.
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    K Number
    K070889
    Device Name
    AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
    Manufacturer
    WALLAC OY
    Date Cleared
    2008-04-14

    (381 days)

    Product Code
    CGZ, JNO
    Regulation Number
    862.1170
    Why did this record match?
    Search-Everything :

    Matched: '862.1725'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoDELFIA® Neonatal IRT L kit is intended for the quantitative determination of human immunoreactive trypsin (ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.
    Device Description
    The AutoDELFIA Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Standards, controls and test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium -labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from the dried blood spots on the filter paper discs. The complete assay requires only one incubation step. Enhancement Solution dissociates europium ions from the labelled antibody into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is the measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.
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