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510(k) Data Aggregation

    K Number
    K190335
    Device Name
    GSP Neonatal Total Galactose kit
    Manufacturer
    PerkinElmer Inc.
    Date Cleared
    2019-11-06

    (265 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Product Code :

    JIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.
    Device Description
    The GSP Neonatal Total Galactose test system measures total galactose, i.e. both galactose and galactose-1-phosphate, using a fluorescent galactose oxidase method. The fluorescence is measured using an excitation wavelength of 505 nm and an emission wavelength of 580 nm. The GSP Neonatal Total Galactose kit contains sufficient reagents to perform 1152 assays. The kit contains Calibrators, Controls, Neonatal Total Galactose Assay Reagent 1, Neonatal Total Galactose Assay Reagent 2, Neonatal Total Galactose Assay Buffer, Neonatal Total Galactose Assay Reconstitution Solution, and Neonatal Extraction Solution.
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    K Number
    K133652
    Device Name
    GSP NEONATAL TOTAL GALACTOSE KIT
    Manufacturer
    WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
    Date Cleared
    2014-04-28

    (152 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Product Code :

    JIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.
    Device Description
    The GSP Neonatal Total Galactose kit contains sufficient reagents to perform 1152 assays. The GSP Neonatal Total Galactose test system measures total galactose, i.e. both galactose and galactose-1-phosphate, using a fluorescent galactose oxidase method. The fluorescence is measured using an excitation wavelength of 505 nm and an emission wavelength of 580 nm. The kit contains Neonatal Total Galactose Assay Reagent 1, Neonatal Total Galactose Assay Reagent 2, Neonatal Total Galactose Assay Buffer, Neonatal Total Galactose Assay Reconstitution Solution, and Neonatal Extraction Solution. Calibrators and Controls are also included.
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    K Number
    K121101
    Device Name
    SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
    Manufacturer
    ASTORIA-PACIFIC,INC.
    Date Cleared
    2013-06-20

    (435 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Product Code :

    JIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPOTCHECK® Neonatal Total Galactose Microplate Reagent Kit is for the quantitative determination of the concentration of Total Galactose (Gal) + galactose-1-phosphate (Gal-1-P)) in whole blood saturated filter paper disks, using a microplate absorbance reader or SPOTCHECK Pro. Measurements of Total Galactose are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for increased concentrations of Total Galactose, and not for monitoring purposes.
    Device Description
    The SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit is a galactose test system. It includes Extraction Solution, Enzyme Reagent, Coenzyme Reagent, Color Reagent, and Stock Standard. Total Galactose is measured colorimetrically following the completion of two enzyme assisted reactions and the color formation reaction. Patient samples of whole blood collected on standardized filter paper are placed into the wells of a 96 well filtration microplate. Extraction solution is added and samples are eluted and incubated. The contents are filtered into a clean flat-bottom microplate. Enzyme Reagent and Coenzyme Reagent are added and the plate is incubated. Color Reagent is then added and the plate is incubated. The absorbance is measured on a microplate reader at a wavelength of 600 nm for the measurement channel and 750 nm for the reference channel. Results are expressed as mg of total galactose per dL of whole blood.
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    K Number
    K071649
    Device Name
    NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
    Manufacturer
    WALLAC OY
    Date Cleared
    2008-08-07

    (416 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Product Code :

    JIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
    Device Description
    The Neonatal Total Galactose kit makes use of a fluorescent galactose oxidase method. The assay measures total galactose, i.e. both galactose and galactose-1-phosphate.
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    K Number
    K990644
    Device Name
    QUANTASE TOTAL GALACTOSE SCREENING ASSAY
    Manufacturer
    QUANTASE LTD.
    Date Cleared
    1999-06-21

    (115 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Product Code :

    JIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantase Total Galactose Screening Assay is an enzymatic colorimetric end-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme. The test is intended as a screening the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The kit is NOT intended for use in monitoring the circulating concentrations of total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.
    Device Description
    enzymatic colorimetric end-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens
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    K Number
    K990654
    Device Name
    QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
    Manufacturer
    QUANTASE LTD.
    Date Cleared
    1999-06-21

    (112 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Product Code :

    JIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantase Total Calactose Screening Assay is an enzymatic colorimetric cad-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme. The test is intended as a screening measuring the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The kit is NOT intended for use in monitoring the circulating concentrations of total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.
    Device Description
    Not Found
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    K Number
    K991498
    Device Name
    ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    1999-06-16

    (48 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Product Code :

    JIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neometrics' ACCUWELL™ Total Galactose kits are intended to be used for the quantitative measurment of Total Galactose in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newborns for galactosemia.
    Device Description
    Not Found
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    K Number
    K950481
    Device Name
    NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
    Manufacturer
    ISOLAB, INC.
    Date Cleared
    1996-02-01

    (363 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Product Code :

    JIA

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