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    K Number
    K123256
    Device Name
    HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-07-03

    (258 days)

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

    HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS

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

    The Human α1-antitrypsin Kit for use on SPAPLUs is designed for the quantitative in vitro determination of a1-antitrypsin in human serum using the SPAPLus turbidimetric analyzer. The measurement of a1- antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a1- antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the "Human alpha-1 Antitrypsin Kit for use on SPAPLUS". It states that the device is substantially equivalent to a predicate device. However, it does not contain any information about the acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    Therefore, I cannot provide the requested information based on the input document.

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