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510(k) Data Aggregation

    K Number
    K964986
    Device Name
    QUANTA LITE IGA GLIADIN ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1997-06-02

    (171 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA LITE IGA GLIADIN ELISA

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

    An Enzyme Linked Immunosorbant Assay (ELISA) for quantitative detection of IgA antibodies to giladin in human serum. semi -Detection of these antibodies is an aid in diagnosis of certain sensitive enteropathies such 98 celiac disease dermatitis herpetiformis. and

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA to INOVA Diagnostics, Inc. regarding their QUANTA Lite™ IgA Gliadin ELISA device. It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    However, the document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory clearance document and not a performance study report.

    Therefore, I cannot provide the requested information based on the given text.

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