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510(k) Data Aggregation

    K Number
    K011780
    Device Name
    K-ASSAY C1-INA
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2001-07-25

    (48 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY C1-INA

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

    The K-ASSAY C1-INA Assay is intended for the quantitative determination of human Complement-1 Inactivators in human plasma by immunoturbidimetric assay for hereditary angioedema. FOR IN VITRO DIAGNOSTIC USE.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an "Indications for Use Statement" for the K-ASSAY Complement-1 Inactivator (C1-INA) device. This document does not include information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

    The information primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls. It does not contain the technical details of the validation studies conducted for the device.

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