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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namegastric emptying breath test
PMA NumberP110015
Date Received04/13/2011
Decision Date04/06/2015
Product Code
PGE[ Registered Establishments with PGE ]
Docket Number 15M-1178
Notice Date 04/14/2015
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order 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.
Approval Order Approval Order