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510(k) Data Aggregation

    K Number
    K033137
    Device Name
    POTENS +
    Manufacturer
    WADA, INC.
    Date Cleared
    2003-12-08

    (69 days)

    Product Code
    JPA
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K962857,K924453
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).

    Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants.

    Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction.

    INR is used to monitor the patients receiving anticoagulation therapy.

    Device Description

    Semi-automated system for in vitro coagulation studies, clot based and photo-optical.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the POTENS+ device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state "acceptance criteria" in a tabular format. Instead, it describes performance characteristics that demonstrated substantial equivalence to predicate devices. The key performance metrics are correlation coefficients (r-values) and precision (Coefficient of Variation - CVs).

    Performance MetricAcceptance Criteria (from predicate equivalence)Reported Device Performance (POTENS+)
    Correlation Coefficients (r-values)
    FibrinogenNot explicitly stated as acceptance criteria, but predicate equivalence was shown for values ≥ 0.973 (based on reported range)0.973 to 0.980
    PTNot explicitly stated, but predicate equivalence was shown for values ≥ 0.95 (based on reported range)0.95 to 0.974
    INRNot explicitly stated, but predicate equivalence was shown for values ≥ 0.919 (based on reported range)0.919 to 0.963
    Precision (Coefficient of Variation - CV)
    FibrinogenNCCLS recommendations (CVs
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