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510(k) Data Aggregation

    K Number
    K100682
    Device Name
    GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
    Manufacturer
    WALLAC OY
    Date Cleared
    2010-07-23

    (135 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Why did this record match?
    Product Code :

    JLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GSP Neonatal 17α-OH-progesterone kit is intended for the quantitative determination of human 17α-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the GSP™ instrument.
    Device Description
    The GSP Neonatal 17x-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled 17-OHP and sample 17-OHP for a limited amount of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibody-bound and free antigen. DELFIA Inducer dissociates europium ions from the labeled antigen into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of 17-OHP in the sample.
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    K Number
    K081922
    Device Name
    AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
    Manufacturer
    WALLAC OY
    Date Cleared
    2009-04-16

    (283 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Why did this record match?
    Product Code :

    JLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoDELFIA® Neonatal 17a-OH-progesterone kit is intended for the quantitative determination of human 17a-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA® automatic immunoassay system.
    Device Description
    The AutoDELFIA Neonatal 17α-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled 17-OHP and sample 17-OHP for a limited amount of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibody-bound and free antigen. Enhancement Solution dissociates europium ions from the labeled antigen 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 inversely proportional to the concentration of 17-OHP in the sample.
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    K Number
    K062534
    Device Name
    ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
    Manufacturer
    DRG INTL., INC.
    Date Cleared
    2008-01-29

    (518 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Why did this record match?
    Product Code :

    JLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K060452
    Device Name
    ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
    Manufacturer
    NEO-GENESIS
    Date Cleared
    2007-03-13

    (385 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Why did this record match?
    Product Code :

    JLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accuwell" 17α-Hydroxyprogesterone EIA Kit is designed for the quantitative measurement of 17α-Hydroxyprogesterone (17-OHP) concentrations in neonatal blood samples that have been collected onto Whatman 903® specimen collection paper. The results are used to screen newborns for classical congenital adrenal hyperplasia (CAH).
    Device Description
    The Accuwell" 17a-Hydroxyprogesterone EIA Kit is a competitive solid phase enzyme immunoassay (ElA) for the quantitative measurement of 17«-Hydroxyprogesterone (17-OHP) concentrations in neonatal blood samples that have been collected onto Whatman S&S 903" specimen collection paper. Standard control, and unknown dried blood spot sample discs are added to specified wells in a 90-well microplate coated with antiserum specific for 17-OHP.
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    K Number
    K050960
    Device Name
    MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
    Manufacturer
    WALLAC OY
    Date Cleared
    2005-07-11

    (84 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Why did this record match?
    Product Code :

    JLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitative determination of 17 a - OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA automatic immunoassay system.
    Device Description
    The AutoDELFIA Neonatal 17α-ΟΗ-progesterone (17-ΟΗΡ) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition between europium-labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibodybound and free antigen. Enhancement Solution dissociates europium ions from the labeled antiserum 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 inversely proportional to the quantity of 17-OHP in the sample.
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    K Number
    K042424
    Device Name
    DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
    Manufacturer
    WALLAC OY
    Date Cleared
    2004-09-30

    (22 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Why did this record match?
    Product Code :

    JLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitative determination of 17 a- OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH).
    Device Description
    The DELFIA Neonatal 17α-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition between europium-labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibodybound and free antigen. Enhancement Solution dissociates europium ions from the labeled antiserum 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 inversely proportional to the quantity of 17-OHP in the sample.
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    K Number
    K042425
    Device Name
    AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
    Manufacturer
    WALLAC OY
    Date Cleared
    2004-09-30

    (22 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Why did this record match?
    Product Code :

    JLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitative determination of 17 a- OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA automatic immunoassay system.
    Device Description
    The AutoDELFIA Neonatal 17α-ΟΗ-progesterone (17-ΟΗΡ) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition between europium-labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibodybound and free antigen. Enhancement Solution dissociates europium ions from the labeled antiserum 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 inversely proportional to the quantity of 17-OHP in the sample.
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    K Number
    K973350
    Device Name
    BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
    Manufacturer
    BIO-RAD
    Date Cleared
    1998-02-09

    (157 days)

    Product Code
    JLX
    Regulation Number
    862.1395
    Why did this record match?
    Product Code :

    JLX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE BIO-RAD MICROPLATE 17- HYDROXYPROGESTERONE (17-OHP) TEST IS DESIGNED FOR THE QUANTITATIVE MEASUREMENT OF ιτα HYDROXYPROGESTERONE IN DRIED BLOOD SPOTS IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE AS AN ALD IN SCREENING NEWBORNS FOR CONGENITAL, ADRENAL HYPERPLASIA.
    Device Description
    Not Found
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