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510(k) Data Aggregation

    K Number
    K240182
    Device Name
    Access EPO
    Manufacturer
    Beckman Coulter Inc
    Date Cleared
    2024-04-22

    (90 days)

    Product Code
    GGT
    Regulation Number
    864.7250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
    Device Description
    The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias. The Access EPO Calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems. The Access EPO assay is a two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with the paramagnetic particles coated with mouse monoclonal anti-EPO, blocking reagent and the alkaline phosphatase conjugate. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
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    K Number
    K183088
    Device Name
    ADVIA Centaur Erythropoietin (EPO) assay
    Manufacturer
    Axis-Shield Diagnostics Limited
    Date Cleared
    2019-08-02

    (269 days)

    Product Code
    GGT
    Regulation Number
    864.7250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADVIA Centaur® Erythropoietin (EPO) assay is for in the quantitative measurement of exythropoitin in pediatric and adult human serum or plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Measurement of erythropoietin is used as an aid in the diagnosis of anemias and polycythemias.
    Device Description
    The ADVIA Centaur EPO assay is a fully automated, one-step sandwich immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium-ester-labeled monoclonal mouse anti-EPO antibody in the Lite Reagent. The Solid Phase consists of mouse anti-EPO monoclonal antibody-coated paramagnetic microparticles.
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    K Number
    K052223
    Device Name
    ACCESS EPO ASSAY
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2006-10-06

    (417 days)

    Product Code
    GGT, JIT
    Regulation Number
    864.7250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias. The Access EPO calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
    Device Description
    The Access® EPO assay consists of the reagent pack and calibrators. Other items needed to perform the assay include the Access substrate and wash buffers.
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    K Number
    K983203
    Device Name
    IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    1999-07-12

    (301 days)

    Product Code
    GGT
    Regulation Number
    864.7250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMMULITE EPO is a solid-phase, two-site sequential chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of erythropoietin (EPO) in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis of anemias and polycythemias.
    Device Description
    IMMULITE® EPO is a solid-phase, two-site chemiluminescent sequential enzyme immunometric assay for use with the IMMULITE® Automated Immunoassay Analyzer
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