13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT

FDA Premarket Approval P110015 S010

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• Device: 13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT
• Generic Name: Gastric Emptying Breath Test
• Applicant: ADVANCED BREATH DIAGNOSTICS105 Westpark Dr.suite 150brentwood, TN 37027 PMA NumberP110015 Supplement NumberS010 Date Received05/03/2022 Decision Date06/01/2022 Product Code PGE Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Date Received: 2022-05-03
• Decision Date: 2022-06-01
• PMA: P110015
• Supplement: S010
• Product Code: PGE
• Advisory Committee: Clinical Chemistry
• Supplement Type: 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 PMA NumberP110015 Supplement NumberS010 Date Received05/03/2022 Decision Date06/01/2022 Product Code PGE Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement ; to Change The Quality Control Testing Of The 13C-Spirulina/Egg Mix. The 13C-Spirulina/Egg Mix Is A Component Of The 13C-Spirulina Gastric Emptying Breath Test (GEBT)

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

Device ID	PMA	Supp
M763K0211	P110015	000