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510(k) Data Aggregation

    K Number
    K965100
    Device Name
    N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-07-14

    (206 days)

    Product Code
    DEM
    Regulation Number
    866.5130
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The N-Assay TIA Alpha-l-Antitrypsin Test Kit is intended for the quantification of human alpha-l-antitrypsin in human serum by immunoturbidimetric assay. The measurement of of alpha-lantitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition. alpha-l-antitrypsin deficiency has been associated with pulmonary emphysema.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the N-Assay TIA Alpha-1-Antitrypsin Test Kit. It states that the device is substantially equivalent to a predicate device for the quantification of human alpha-1-antitrypsin in human serum. As such, the document does not contain specific acceptance criteria, a study design, or performance data for this device.

    The information typically requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this type of regulatory letter. This letter confirms regulatory clearance, not the detailed technical validation study.

    Therefore, I cannot provide the requested information from the given text.

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