GASTRIC EMPTYING BREATH TEST (GEBT)
FDA premarket approval P110015 · decided 2015-04-06
Approval details
- PMA number
- P110015
- Trade name
- GASTRIC EMPTYING BREATH TEST (GEBT)
- Generic name
- Gastric Emptying Breath Test
- Applicant
- Advanced Breath Diagnostics
- Date received
- 2011-04-13
- Decision date
- 2015-04-06
- Days to decision
- 1454 days
- Decision code
- APPR
- Product code
- PGE
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Brentwood, TN
- 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
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