Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K042687
    Device Name
    ENZYGNOST F+2 (MONOCLONAL) TEST KIT
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2004-12-10

    (72 days)

    Product Code
    MIF
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    MIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enzygnost F1+2 (monoclonal) is an enzyme immunoassay for the quantitative determination of human prothrombin F1+2 in plasma. Measurement of F1+2 is used as an aid in the diagnosis, monitoring, and evaluation of acquired or hereditary blood coagulation disorders. It is indicated as an aid in assessing risk of thrombosis and in monitoring efficacy of anticoagulant therapy.
    Device Description
    The Enzygnost™ F1+2 Test Kit is an enzyme immunoassay based on the sandwich principle in microtiter format utilizing monoclonal mouse antibodies. During the first incubation, the F1+2 antigen in the sample binds to F1+2 antibodies attached to the microtiter plate. After washing, peroxidase-conjugated antibodies to human prothrombin are bound to a free F1+2 determinant in a second reaction. The excess enzyme-conjugated antibodies are removed by washing; the bound enzyme activity is then determined. The enzymatic reaction between hydrogen peroxide and chromogen is terminated by the addition of dilute sulfuric acid. The color intensity, which is proportional to the concentration of F1+2, is determined photometrically and quantified by means of a calibration curve based on the standards included in the kit.
    Ask a Question
    K Number
    K964934
    Device Name
    THROMBONOSTIKA F1.2
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    1997-03-18

    (99 days)

    Product Code
    MIF
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    MIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thrombonostika F1.2 is an enzymed-linked immunosorbent assay for the quantitative determination of prothrombin activation fragment 1.2 (F1.2) in human plasma. It is indicated as an aid to both assess the risk of thrombosis and monitor the efficacy of anticoagulant therapy.
    Device Description
    Thrombonostika F1.2 is a two-stage enzymed-linked immunosorbent assay for the prothrombin activation peptide F.12. The high specificity of the solid-phase anti-F1.2 monoclonal antibody allows quantitation of nanomolar F1.2 in the presence of micromolar prothrombin that is typically found in plasma. Rabbit polyclonal antibodies to the calcium-dependent conformer of prothrombin (i.e., the amino terminal region present on both prothrombin and F1.2 ) coupled to horseradish peroxidase (HRP) serves as the conjugate with tetramethylbenzidine (TMB) used as the substrate. In the first stage, test sample or calibrator is incubated with a monoclonal F1.2-specific antibody (murine) coated on a microelisa well. F1.2 binds to the solid-phase antibody. Following an incubation, unbound proteins (including prothrombin) are aspirated and the well washed with buffer. In the second stage, conjugate (rabbit) labeled with HRP is added. The enzyme-labeled antibody is bound to the solid-phase F1.2 complex. Following a wash and incubation with TMB substrate, blue color is produced that turns yellow hen the reaction is stopped with stop solution. Within limits, the amount of prothrombin fragment 1.2 is proportional to the color development.
    Ask a Question
    K Number
    K962176
    Device Name
    TPP
    Manufacturer
    PANBIO, INC.
    Date Cleared
    1996-10-18

    (135 days)

    Product Code
    MIF
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    MIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABS, Inc. TpP™ EIA is an enzyme linked immunoassay for the quantitative determination of soluble fibrin polymers in human plasma. It is indicated as an aid in assessing the risk of intravascular thrombosis and monitoring the efficacy of anticoagulant (heparin) therapy.
    Device Description
    The TpP™ EIA employs a murine monoclonal antibody (MAb), specific for soluble fibrin polymer, as a capture antibody immobilized on a microtiter plate (MTP). This MAb recognizes a conformational epitope present only on the TpP™ entities but which is absent from fibrinogen and degradation products of fibrin and fibrinogen. During the first incubation phase TpP™ in human plasma specimens bind to the capture antibody. Afterwards the plate is rinsed, and a conjugate, another murine monoclonal antibody, labeled with horseradish peroxidase (HRP) is added to the well. This peroxidase conjugated MAb binds to a separate site on the TpP™ molecule during a second incubation period. Excess enzyme conjugated MAb is washed out and a subsequent application and incubation with tetramethylbenzidine (TMB) substrate follows. The reaction after TMB incubation is terminated with dilute sulfuric acid. The level of the TpP™ present in the specimen sample is determined colorimetrically from the enzymatic activity of detection MAb conjugate. The intensity of the color is proportional to the concentration of TpP™. Calibrator standard is provided with the kit.
    Ask a Question

    Page 1 of 1