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510(k) Data Aggregation

    K Number
    K024334
    Device Name
    QUANTA LITE H.PYLORI IGA ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2003-03-27

    (91 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QUANTA Lite™ H. pylori IgA kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgA antibodies to H. pylori (Helicobacter pylori) in human serum. This test is intended to aid in the diagnosis of H. pylori infection in adult patients 18 years or older with clinical signs and symptoms of gastrointestinal disease. The QUANTA Lite™ H. pylori IgA should be performed and interpreted in conjunction with the QUANTA Lite™ H. pylori IgG for the detection of IgG antibodies to H.pylori .

    Device Description

    The QUANTA Lite™ H. pylori IgA kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgA antibodies to H. pylori (Helicobacter pylori) in human serum.

    AI/ML Overview

    This document is a marketing approval letter for a medical device called QUANTA Lite™ H. pylori IgA ELISA. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    To answer your request, I would need a study report or a different type of document that details the performance data and acceptance criteria for the QUANTA Lite™ H. pylori IgA ELISA device.

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