PGE

Gastric Emptying Breath Test

Product code: PGE
Device name: Gastric Emptying Breath Test
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

Gastric emptying breath tests are 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.The test system typically utilizes a Mass Spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples following the ingestion of a 13C-labeled test meal.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PGE

Classification and pathway per current FDA publications. Data from openFDA (CC0).