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510(k) Data Aggregation

    K Number
    K173568
    Device Name
    NeoBase 2 Non-derivatized MSMS Kit
    Manufacturer
    Wallac Oy, Subsidiary of PerkinElmer, Inc.
    Date Cleared
    2018-09-04

    (288 days)

    Product Code
    NQL
    Regulation Number
    862.1055
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wallac Oy, Subsidiary of PerkinElmer, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analytis of these analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
    Device Description
    Not Found
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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?
    Applicant Name (Manufacturer) :

    WALLAC OY, SUBSIDIARY OF PERKINELMER

    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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