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510(k) Data Aggregation

    K Number
    K050661
    Device Name
    HEMOSIL FACTOR II DEFICIENT PLASMA
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2005-05-02

    (48 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K900133,K002400
    Why did this record match?
    Device Name :

    HEMOSIL FACTOR II DEFICIENT PLASMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HemosIL Factor II Deficient Plasma is human plasma immunodepleted of factor II and intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

    Device Description

    HemosIL Factor II Deficient Plasma is human plasma immunodepleted of factor II and intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.

    Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in factor II. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor II in the patient plasma, interpolated from a calibration curve.

    AI/ML Overview

    The provided 510(k) summary for the HemosIL Factor II Deficient Plasma does not explicitly state acceptance criteria in the form of pre-defined thresholds that the device had to meet. Instead, the study demonstrates that the new device is "substantially equivalent" to predicate devices by showing comparable performance.

    However, we can infer performance metrics that were deemed acceptable for substantial equivalence based on the presented data. The study primarily relies on method comparison and precision data.

    Here's a breakdown of the information requested, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    As noted, explicit "acceptance criteria" are not given. The study aims to demonstrate substantial equivalence to predicate devices. We can infer that correlation coefficients (r) close to 1.0, slopes close to 1.0, and small intercepts compared to predicate devices, along with acceptable precision (%CV), were considered evidence of substantial equivalence.

    Performance MetricImplied "Acceptance Range" (for substantial equivalence)Reported Device Performance (Range Across Systems)
    Method Comparison (vs. Predicate/Reference Device)
    Correlation Coefficient (r)Close to 1.0 (e.g., typically > 0.95 or 0.98 for strong correlation in equivalent devices)0.9855 to 0.9954
    SlopeClose to 1.0 (e.g., typically 0.95-1.05)1.0357 to 1.0603
    InterceptClose to 0 (e.g., often within a small clinically acceptable range)-4.6831 to 1.0196
    Within Run Precision (%CV)Typically a low percentage, e.g.,
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