BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Test, Urea Adult And Pediatric (Breath),

    PMA: P100025 · Decision Feb 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Urea Adult And Pediatric (Breath),
    Trade Name
    BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
    PMA Number
    P100025
    Device Class
    FDA Class 3
    Product Code
    OZA
    Generic Name
    Test, urea adult and pediatric (breath),
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    February 22, 2012
    Date Received
    June 22, 2010
    Expedited Review
    N
    Docket Number
    12M-0207

    Advisory Committee Statement

    APPROVAL FOR THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0. THE BREATHTEK UBT KIT IS CURRENTLY CLEARED FOR USE INADULT PATIENTS UNDER 510(K) PREMARKET NOTIFICATION, K014225, AND THE PRANACTIN-CITRIC IS APPROVED UNDER NDA 20-586/S-004. THIS DEVICE IS INDICATED FOR: THE BREATHTEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) IS INTENDED FOR USE IN THE QUALITATIVE DETECTION OF UREASE ASSOCIATED WITH H. PYLORI IN THE HUMAN STOMACH AND IS INDICATED AS AN AID IN THE INITIAL DIAGNOSIS AND POST-TREATMENT MONITORING OF H. PYLORI INFECTION IN ADULTS, AND PEDIATRIC PATIENTS 3 TO 17 YEARS OLD. THE TEST MAY BE USED FORMONITORING TREATMENT IF USED AT 4 WEEKS FOLLOWING COMPLETION OF THERAPY. FOR THESE PURPOSES, THE SYSTEM UTILIZES AN INFRARED SPECTROPHOTOMETER FOR THE MEASUREMENT OF THE RATIO OF 13CO2 TO 12CO2 IN BREATH SAMPLES, IN CLINICAL LABORATORIES AND POINT-OF-CARE SETTINGS. THE PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), PROVIDED AS A WEB-BASED CALCULATION PROGRAM, IS REQUIRED TO OBTAIN PEDIATRIC TEST RESULTS. THE BREATHTEK UBT KIT IS FORADMINISTRATION BY A HEALTH CARE PROFESSIONAL, AS PRESCRIBED BY A PHYSICIAN.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OZA Test, Urea Adult And Pediatric (Breath),