PGE · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
PGE
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
TX
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.