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510(k) Data Aggregation

    K Number
    K012588
    Device Name
    OXOID PYLORI TEST KIT, MODEL DR0130M
    Manufacturer
    OXOID, LTD.
    Date Cleared
    2001-12-10

    (122 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OXOID PYLORI TEST KIT, MODEL DR0130M

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

    Oxoid Pylori Test Kit is a rapid latex agglutination test for the qualitative detection of Helicobacter onlori total antibodies in serum as an aid in the diagnosis of infections by H. pylori. The product is intended for use to test patients 18 years and older, with symptoms of gastro-intestinal disorders.

    Device Description

    rapid latex agglutination test

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance. The document is a 510(k) clearance letter from the FDA for the Oxoid Pylori Test Kit, focusing on its substantial equivalence to a predicate device and its intended use. It does not contain the detailed study information you are requesting.

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