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.
| Device | GASTRIC EMPTYING BREATH TEST (GEBT) |
| Classification Name | Gastric Emptying Breath Test |
| Generic Name | Gastric Emptying Breath Test |
| Applicant | ADVANCED BREATH DIAGNOSTICS |
| Date Received | 2011-04-13 |
| Decision Date | 2015-04-06 |
| Notice Date | 2015-04-14 |
| PMA | P110015 |
| Supplement | S |
| Product Code | PGE |
| Docket Number | 15M-1178 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ADVANCED BREATH DIAGNOSTICS 105 Westpark Dr. suite 150 brentwood, TN 37027 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P110015 | | Original Filing |
| S010 |
2022-05-03 |
30-day Notice |
| S009 | | |
| S008 |
2021-03-16 |
Real-time Process |
| S007 |
2021-02-23 |
30-day Notice |
| S006 |
2019-10-30 |
30-day Notice |
| S005 |
2019-03-05 |
135 Review Track For 30-day Notice |
| S004 |
2018-06-14 |
30-day Notice |
| S003 | | |
| S002 |
2016-07-15 |
135 Review Track For 30-day Notice |
| S001 | | |
NIH GUDID Devices