PGE — Gastric Emptying Breath Test Class III
FDA product code PGE covers "Gastric Emptying Breath Test", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PGE
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Unknown
- Implant
- No
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.