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510(k) Data Aggregation

    K Number
    K021541
    Device Name
    NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
    Manufacturer
    PERKINELMER LIFE SCIENCES
    Date Cleared
    2002-10-28

    (171 days)

    Product Code
    JNB, CDR, JJE
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoGram PKU Tandem Mass Spectrometry Kit is intended for screening for Phenvlketonuria (PKU). It involves the quantitative determination of phenvlalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.
    Device Description
    The assay involves the extraction of dried blood spots with a solution containing stable, isotopically labeled internal standards. The response of each amino acid relative to the isotopically labeled standards in the kit is proportional to their actual concentration. The analysis of the material is performed on a tandem mass spectrometer. Control material contained in the kit allows for verification of performance for the test run.
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    K Number
    K003584
    Device Name
    NEOLYNX SCREENING APPLICATION MANAGER
    Manufacturer
    MICROMASS, INC.
    Date Cleared
    2001-03-19

    (119 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000754
    Device Name
    QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
    Manufacturer
    QUANTASE LTD.
    Date Cleared
    2000-06-19

    (103 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K984463
    Device Name
    QUANTASE PHE/GAL SCREENING ASSAY
    Manufacturer
    QUANTASE LTD.
    Date Cleared
    1999-02-16

    (62 days)

    Product Code
    JNB, JIA, JIX, JJY
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantase Phe/Gal Screening Assay is an eazymatic colorinetic cast-point mechod for the decired blood more maciment I he Quantist Parcelling Possy is an enzintate e. siactose-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 method for measuring the L-phenylalanine and total D(+)galactose I he ust is miched is a screening meason for messaring are not diagnostic per se of phenylkstomuria or galactosemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The lit is NOT intended for use in monitoring the circulating concentrations of L-phenylalanine and total I be an is NOT measurer and galactosenic patients respectively, nor to detect ante-natal phenylketonucia and galactosemia or maternal phenylketonuria
    Device Description
    Not Found
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    K Number
    K982307
    Device Name
    WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
    Manufacturer
    WALLAC, INC.
    Date Cleared
    1999-02-02

    (216 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Leucine Test is for the quantitation of leucine, and valine in blood specimens dried on filter paper. It is intended for use as a primary test for screening babies for Maple Syrup Urine Disease.
    Device Description
    Not Found
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    K Number
    K974047
    Device Name
    ACCUWELL PHENYLALANINE ASSAY
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    1997-12-05

    (42 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neometrics' ACCUWELL™ Phenylalanine kits are intended to be used for the quantitative measurement of phenylalanine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen for phenylketonuria disease.
    Device Description
    Not Found
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    K Number
    K963040
    Device Name
    MANUAL PHENYLALANINE TEST
    Manufacturer
    BIO-RAD
    Date Cleared
    1996-10-01

    (57 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960437
    Device Name
    RADIAS PHENYLALANINE TEST
    Manufacturer
    BIO-RAD
    Date Cleared
    1996-08-16

    (198 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961515
    Device Name
    QUANTASE PHENYLALANINE ASSAY
    Manufacturer
    SHIELD DIAGNOSTICS, LTD.
    Date Cleared
    1996-06-12

    (63 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K943547
    Device Name
    PHENYLALANINE TEST KIT
    Manufacturer
    ISOLAB, INC.
    Date Cleared
    1996-01-26

    (554 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Product Code :

    JNB

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