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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
    Why did this record match?
    Product Code :

    GGT

    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
    Why did this record match?
    Product Code :

    GGT

    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
    Why did this record match?
    Product Code :

    GGT

    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
    K992799
    Device Name
    SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
    Manufacturer
    SANGUI BIOTECH, INC.
    Date Cleared
    2000-06-07

    (293 days)

    Product Code
    GGT
    Regulation Number
    864.7250
    Why did this record match?
    Product Code :

    GGT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this product is the quantitative determination of erythropoietin levels in human serum. 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.
    Device Description
    Quantitative determination of EPO [Erythropoietin] in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
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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
    Why did this record match?
    Product Code :

    GGT

    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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    K Number
    K980737
    Device Name
    ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Date Cleared
    1999-03-23

    (391 days)

    Product Code
    GGT
    Regulation Number
    864.7250
    Why did this record match?
    Product Code :

    GGT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nichols Advantage™ Chemiluminescence Erythropoietin Immunoassay is intended for use with the Nichols Advantage™ Specialty System for the quantitative determination of erythropoietin concentrations in human serum as an adjunct in the diagnosis of anemia and polycythemia.
    Device Description
    The Nichols Advantage™ EPO assay is a two-site chemiluminescence assay. Total assay duration is 30 minutes at 37°C. 14 Incubation: 20 minutes at 37℃. Sample or control (200uL), biotinylated polyclonal antibody (40uL), acridinium labeled mouse monoclonal antibody (10uL) are pipetted into a reaction well on the cuvette strip. Each antibody binds to a separate and distinct antigenic site on EPO to form a sandwich complex. 204 Incubation: 10 minutes at 37°C. Streptavidin coated magnetic particles (20uL) are added to the reaction mixture. After the 10 minute incubation, the sandwich complex is bound to the solid phase via the high affinity interaction of blotin and streptavidin. The reaction mixture is aspirated from the reaction well after the streptavidin magnetic particles are magnetically capfured onto the surface of the reaction well wall. Acridinum esters emit light upon treatment with hydrogen peroxide and an alkaline solution. The Trigger 1 solution contains hydrogen peroxide in dilute acid and Trigger 2 solution contains sodium hydroxide. The system automatically injects Trigger 1 and 2 into the reaction well which oxidizes the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light which is quantified in 2 seconds, and is expressed in relative light units (RLU) by the integrated system luminometer. The amount of bound labeled antibody in RLU's is directly proportional to the concentration of EPO in the sample. 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 codes.
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    K Number
    K952559
    Device Name
    ERYTHROPOIETIN IMMUNOASSAY KIT
    Manufacturer
    NICHOLS INSTITUTE
    Date Cleared
    1996-05-29

    (362 days)

    Product Code
    GGT
    Regulation Number
    864.7250
    Why did this record match?
    Product Code :

    GGT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954898
    Device Name
    PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
    Manufacturer
    GENZYME CORP.
    Date Cleared
    1996-02-05

    (138 days)

    Product Code
    GGT
    Regulation Number
    864.7250
    Why did this record match?
    Product Code :

    GGT

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

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