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510(k) Data Aggregation

    K Number
    K193103
    Device Name
    NeoBase 2 Non-derivatized MSMS Kit
    Manufacturer
    PerkinElmer Inc.
    Date Cleared
    2020-02-07

    (91 days)

    Product Code
    NQL, NOL
    Regulation Number
    862.1055
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    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 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
    Each NeoBase 2 Non-derivatized MSMS kit contains reagents for 960 assays. The kit is designed to be used with NeoBase 2 Non-derivatized Assay Solutions consisting of Neo MSMS Flow Solvent and NeoBase 2 Extraction Solution and NeoBase 2 Succinylacetone Assay Solution. - NeoBase 2 Internal Standards - 1 vial - NeoBase 2 Controls Low, High - 3 filter paper cassettes (Whatman, no. 903) containing 3 spots of each level per cassette - Microplate, U-bottomed - 20 plates - Adhesive microplate covers - 20 sheets - Barcode labels for the plates - 30 pcs (10 different barcodes, 3 pcs of each) - Lot-specific quality control certificate This kit contains components manufactured from human blood. The source materials have been tested by FDA-approved methods for hepatitis B surface antigen, anti-hepatitis C and anti-HIV 1 and 2 antibodies and found to be negative. Instruments used: - . QSight® 210 MD Screening System is comprised of: - QSight® 210 MD Mass Spectrometer - QSight® HC Autosampler MD - QSight® Binary Pump MD ● - Simplicity™ 3Q MD Software - PerkinElmer MSMS Workstation software ●
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    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?
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    Matched: '862.1055'

    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
    K093916
    Device Name
    NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
    Manufacturer
    PERKINELMER, INC.
    Date Cleared
    2010-08-23

    (244 days)

    Product Code
    NQL
    Regulation Number
    862.1055
    Why did this record match?
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    Matched: '862.1055'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neobase Non-derivatized MSMS reagent kit (for use on the PerkinElmer TQD MSMS Screening System) is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes (Table 1) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
    Device Description
    The measurement of amino acids, succinylacetone, free carnitine, and acylcarnitines with the NeoBase assay involves extraction of dried blood spots from newborns with a solution containing stable-isotope labeled internal standards and analysis using a tandem mass spectrometry (MSMS) system. The each analyte relative to their response of internal stable-isotope labeled corresponding standard is proportional to analyte concentration.
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    K Number
    K083130
    Device Name
    NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
    Manufacturer
    PERKINELMER, INC.
    Date Cleared
    2009-07-09

    (259 days)

    Product Code
    NQL, NOL
    Regulation Number
    862.1055
    Why did this record match?
    Search-Everything :

    Matched: '862.1055'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoBase Non-derivatized MSMS reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes (Table 1) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
    Device Description
    The measurement of amino acids, succinylacetone, free carnitine, and acylcarnitines with the NeoBase assay involves extraction of dried blood spots from newborns with a solution containing stable-isotope labeled internal standards and analysis using a tandem mass spectrometry (MSMS) system. The response of each analyte relative to their corresponding stable-isotope labeled internal standard is proportional to analyte concentration.
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