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510(k) Data Aggregation

    K Number
    K983898
    Device Name
    BIOCLOT APC SENSITIVITY
    Manufacturer
    BIOPOOL INTL., INC.
    Date Cleared
    1999-01-06

    (64 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOCLOT APC SENSITIVITY

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

    Bioclot® aPC Sensitivity is intended for the determination of resistance to activated protein C in human plasma using a clotting assay.

    Activated Protein C Resistance (aPC) is a hereditary defect which appears to play an important role in thrombophilia.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) approval letter for the Bioclot® aPC Sensitivity Kit does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

    The document is a letter indicating substantial equivalence to a predicate device, allowing the kit to be marketed. It does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about sample sizes for test or training sets, data provenance, or ground truth establishment.
    • Information on expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
    • Results from standalone algorithm performance studies.

    Therefore, I cannot fulfill your request based on the provided input.

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