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510(k) Data Aggregation

    K Number
    K992188
    Device Name
    NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Date Cleared
    1999-12-06

    (160 days)

    Product Code
    JNM
    Regulation Number
    866.5880
    Why did this record match?
    Product Code :

    JNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of Soluble Transferrin Receptor in human serum, EDTA and Heparin plasma as an adjunct in the diagnosis of Iron Deficiency Anaemia and for the differential diagnosis of Iron Deficiency Anaemia and Anaemia of Chronic Disease.
    Device Description
    The Nichols Advantage® Soluble Transferrin Receptor Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System.
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    K Number
    K981208
    Device Name
    TFR
    Manufacturer
    RAMCO LABORATORIES, INC.
    Date Cleared
    1998-10-21

    (202 days)

    Product Code
    JNM
    Regulation Number
    866.5880
    Why did this record match?
    Product Code :

    JNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TFR assay is an in vitro enzyme immunoassay for quantifying the concentration of transferrin receptor in human serum or plasma to aid in the diagnosis of iron deficiency anemia, particularly in the presence of other disease states.
    Device Description
    The TFR assay is an in vitro enzyme immunoassay based upon the double antibody sandwich method. Plasma or serum samples are diluted in buffer and pipetted into microwells pre-coated with polyclonal antibody to transferrin receptor. Horseradish peroxidase conjugated antibody specific for serum transferrin receptor (STR) is added to the wells and incubated. During this incubation, the STR binds to the polyclonal antibodies adsorbed to the wells and the HRP-conjugated second antibodies bind to the captured STR. Any unbound STR and excess HRP-conjugate are washed from the wells. Enzyme substrate is added to the wells and allowed to incubate, a stop solution is then added to stop the reaction and the intensity of the yellow product is measured in a microplate reader. The optical density of the resulting solution is directly proportional to the concentration of the STR in the standard samples. A standard curve is generated from the STR standards provided in the assay and the concentration of STR in the unknown sample is determined by comparing the unknown's optical density reading with the standard curve graph.
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    K Number
    K970718
    Device Name
    QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
    Manufacturer
    R & D SYSTEMS, INC.
    Date Cleared
    1997-05-27

    (90 days)

    Product Code
    JNM
    Regulation Number
    866.5880
    Why did this record match?
    Product Code :

    JNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
    Device Description
    The product is a microtiter-plate-based sandwich enzyme immunoassay for soluble transferrin receptor.
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