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510(k) Data Aggregation

    K Number
    K234052
    Device Name
    Access Ferritin
    Manufacturer
    Beckman Coulter, Inc
    Date Cleared
    2024-03-20

    (90 days)

    Product Code
    JMG
    Regulation Number
    866.5340
    Why did this record match?
    Product Code :

    JMG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.
    Device Description
    The Access Ferritin assay is a sandwich immunoenzymatic assay. The Access Ferritin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Ferritin assay reagent pack, Access Ferritin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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    K Number
    K052082
    Device Name
    FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2005-08-19

    (17 days)

    Product Code
    JMG
    Regulation Number
    866.5340
    Why did this record match?
    Product Code :

    JMG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
    Device Description
    The Access Ferritin reagents, Access Ferritin Calibrators and the Access Wash Buffer used in conjunction with the Access Immunoassay Analyzers (Access, Access 2, Synchron LX® 725, and UniCel DxI™ 800) comprise the Access Immunoassay Systems for the quantitative determination of ferritin levels in human serum and plasma (heparin).
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    K Number
    K964282
    Device Name
    TINA-QUANT FERRITIN ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1997-07-30

    (275 days)

    Product Code
    JMG
    Regulation Number
    866.5340
    Why did this record match?
    Product Code :

    JMG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunological.in. vitro immunoturbidometric.test for the quantitative determination of ferritin.in . .... human serum and plasma using clinical-chemistry analyzers.
    Device Description
    The Ferritin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing ferritin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution containing fine latex particles coated with polyclonal anti-human ferritin antibodies (R₂ reagent) is added to mixture of the first step. The antibody-coated particles will bind to the ferritin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of ferritin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of ferritin in the sample is directly proportional to the amount of turbidity formed.
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    K Number
    K971833
    Device Name
    ELECSYS FERRITIN
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1997-06-02

    (14 days)

    Product Code
    JMG
    Regulation Number
    866.5340
    Why did this record match?
    Product Code :

    JMG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" us intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
    Device Description
    The Elecsys® Ferritin employs a sandwich test principle with monoclonal antibodies directed against ferritin and with streptavidin microparticles and electrochemiluminescence detection. Total duration of assay: 18 minutes. • 1st Incubation: 15 µl of sample a biotinylated monoclonal ferritin-specific antibody and a monoclonal ferritin-specific antibody labeled with a ruthenium complex react to form a sandwich complex. • 2nd Incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
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    K Number
    K963498
    Device Name
    FERR FLEX REAGENT CARTRIDGE
    Manufacturer
    DADE CHEMISTRY SYSTEMS, INC.
    Date Cleared
    1997-01-24

    (143 days)

    Product Code
    JMG
    Regulation Number
    866.5340
    Why did this record match?
    Product Code :

    JMG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FERR Flex™ reagent cartridge is used on the Dimension™ RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma.
    Device Description
    The FERR Flex™ Reagent Cartridge is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles, coated with monoclonal anitbodies specific for ferritin and conjugate reagent consisting of B-galactosidase labeled monoclonal antibodies specific for a second binding site on ferritin to form a particle-ferritin-conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound Bgalactosidase is combined with a chromogenic substrate chlorophenl red-b-dgalactopyranoside (CPRG). Hydrolvsis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of ferritin in the original sample.
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