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510(k) Data Aggregation

    K Number
    K972981
    Device Name
    SHIELD HELICO-G2 ELISA KIT
    Manufacturer
    SHIELD DIAGNOSTICS, LTD.
    Date Cleared
    1998-03-17

    (218 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 Shield Helico G2 kit is a qualitative indirect enzyme immunoassay for the detection of the IgG class of antibodies for Helicobacter pylori (H pylori) in human serum or plasma (EDTA or Heparin ). The test is intended as an aid in the diagnosis of H pylori infection in adults and is not definitive in isolation. Antibodies represent one parameter in a multi-criteria diagnostic process.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry but this document does not contain the requested information. The document is a 510(k) clearance letter from the FDA for a device called "Shield Helico G2 Elisa Kit." It mainly discusses regulatory aspects, such as substantial equivalence, classification, and general controls. It does not provide details about acceptance criteria, study methodologies, sample sizes, or ground truth establishment for the device's performance.

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