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    K Number
    K993444
    Device Name
    K-ASSAY ALPHA-1 AT
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-11-24

    (43 days)

    Product Code
    DEM
    Regulation Number
    866.5130
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY ALPHA-1 AT

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

    The K-ASSAY Alpha-1 AT Assay is intended to be used for the quantitative determination of Alpha-1-Antitrypsin in human serum by immunoturbidimetric assay. Measurement of Alpha-1-Antitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, Alpha-1-Antitrypsin deficiency has been associated with pulmonary emphysema. FOR IN VITRO DIAGNOSTIC USE.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the K-ASSAY Alpha-1 AT device. It confirms the device's substantial equivalence to a legally marketed predicate device for the quantitative determination of Alpha-1-Antitrypsin in human serum by immunoturbidimetric assay.

    However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. These details are typically found in the actual 510(k) submission document, which this letter is a response to.

    Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided text.

    The document states the "Indications for Use" for the device, which are:

    • Quantitative determination of Alpha-1-Antitrypsin in human serum by immunoturbidimetric assay.
    • Aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver.
    • In addition, Alpha-1-Antitrypsin deficiency has been associated with pulmonary emphysema.

    To answer your request thoroughly, I would need to review the actual 510(k) submission for K993444, not just the FDA's response letter.

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