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510(k) Data Aggregation

    K Number
    K993482
    Device Name
    K-ASSAY FIBRINOGEN
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-12-06

    (53 days)

    Product Code
    GIS
    Regulation Number
    864.7340
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY FIBRINOGEN

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

    The K-ASSAY Fibrinogen Assay is intended to be used to determine the fibrinogen levels in disseminated intravascular coagulation (non-localized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrinogen in a blood clot.) FOR IN VITRO DIAGNOSTIC USE.

    Device Description

    Not Found

    AI/ML Overview

    The provided text details an FDA 510(k) clearance for the K-ASSAY Fibrinogen device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    The document is a clearance letter from the FDA to Kamiya Biomedical Company, stating that their K-ASSAY Fibrinogen device is substantially equivalent to a legally marketed predicate device. It outlines the regulatory class, product code, and marketing permissions. The "Indications for Use Statement" simply describes what the device is intended for (determining fibrinogen levels in disseminated intravascular coagulation and primary fibrinolysis for in vitro diagnostic use).

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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