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510(k) Data Aggregation

    K Number
    K980782
    Device Name
    STAT-SIMPLE PYLORI
    Manufacturer
    SALIVA DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1998-08-05

    (156 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

    Stat-Simple™ pylori is a colloidal-gold based immunoassay for use in the qualitative detection of circulating IgG antibody to Helicobacter pylori in human whole blood or serum. The blood specimen is obtained by fingerstick using a lancet designed for that purpose. This test is intended for use in the clinical laboratory or the physician's office. It is intended for use as an aid to diagnosis of H. pylori infection in persons with gastrointestinal symptoms consistent with diseases related to H. pylori infection (1). FOR IN VITRO DIAGNOSTIC USE.

    Device Description

    Stat-Simple™ pylori is a colloidal-gold based immunoassay.

    AI/ML Overview

    This document is a marketing authorization letter for the device "Stat-Simple Pylori" and an "Indications For Use" statement. It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs as requested. Therefore, I cannot fulfill your request with the provided text.

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