Approval of the qualification of additional service providers and the addition of a new test specification for the lyophilized egg (excipient) used in the production of the drug component of the 13c-spirulina gastric emptying breath test (gebt).
| Device | 13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT) |
| Classification Name | Gastric Emptying Breath Test |
| Generic Name | Gastric Emptying Breath Test |
| Applicant | ADVANCED BREATH DIAGNOSTICS |
| Date Received | 2016-07-15 |
| Decision Date | 2017-01-06 |
| PMA | P110015 |
| Supplement | S002 |
| Product Code | PGE |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ADVANCED BREATH DIAGNOSTICS 105 Westpark Dr. suite 150 brentwood, TN 37027 |
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