BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gastric Emptying Breath Test

    PMA: P110015 · Decision Apr 6, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Gastric Emptying Breath Test
    Trade Name
    GASTRIC EMPTYING BREATH TEST (GEBT)
    PMA Number
    P110015
    Device Class
    FDA Class 3
    Product Code
    PGE
    Generic Name
    Gastric Emptying Breath Test
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 6, 2015
    Date Received
    April 13, 2011
    Expedited Review
    N
    Docket Number
    15M-1178

    Advisory Committee Statement

    APPROVAL FOR THE GASTRIC EMPTYING BREATH TEST (GEBT). THIS DEVICE, TO BE USED WITH THE GEBT TEST MEAL, IS INTENDED FOR USE IN THE MEASUREMENT OF THE RATE OF GASTRIC EMPTYING OF SOLIDS AND AS AN AID IN THE DIAGNOSIS OF DELAYED GASTRIC EMPTYING (GASTROPARESIS) IN ADULT HUMANS WHO ARE SYMPTOMATIC FOR GASTOPARESIS. FOR THESE PURPOSES, THE TEST SYSTEM UTILIZES A GAS ISOTOPE RATIO MASS SPECTROMETER (GIRMS) FOR THE MEASUREMENT OF THE RATIO OF 13CO2 TO 12CO2 IN BREATH SAMPLES. THE GEBT PROCEDURE SHOULD BE ADMINISTERED UNDER SUPERVISION OF A HEALTH CARE PROFESSIONAL ALTHOUGH NO SPECIALIZED FACILITIES OR SPECIALLY LICENSED PERSONNEL ARE REQUIRED.

    Classifications

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

    Product Code Device Name
    PGE Gastric Emptying Breath Test