LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982790
    Device Name
    QUANTA LITE H. PYLORI IGG ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1998-11-04

    (86 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 IgG kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibodies to H. pylori (Helicobacter pylori) in patient sera. This test is intended to aid in the diagnosis of H. pylori infections in adult patients with clinical signs and symptoms of gastrointestinal disease. This test is for in vitro diagnostic use.

    Device Description

    enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibodies to H. pylori (Helicobacter pylori) in patient sera.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the QUANTA Lite™ H. pylori IgG ELISA device. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment relevant to the device's accuracy or effectiveness study.

    Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence, not on the detailed performance characteristics and study design of the device itself.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1