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    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
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K922934
    Why did this record match?
    Device Name :

    ENZYGNOST F+2 (MONOCLONAL) TEST KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    Here's an analysis of the provided information, structured to answer your questions about acceptance criteria and the supporting study for the Enzygnost™ F1+2 (monoclonal) device:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Implicit)Reported Device Performance
    Correlation to Predicate DeviceHigh correlation coefficient (target usually > 0.9)0.96
    Slope (vs. predicate)Slope close to 10.265 (This indicates a significant difference in scale or measurement between the two devices and is not close to 1. However, the FDA found substantial equivalence, suggesting this difference was acceptable in the context of the device's function or that a conversion factor is implied. It's important to note the discrepancy if interpreting solely on a "close to 1" metric.)
    Intercept (vs. predicate)Intercept close to 0-29.378 (Similar to the slope, this indicates a bias between the two devices. The FDA's acceptance suggests this was deemed acceptable.)
    Within-Run Precision (CV)Low coefficient of variation (typical
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