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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceBREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
Generic NameTest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantMeridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati, OH 45244
PMA NumberP100025
Supplement NumberS007
Date Received08/08/2014
Decision Date02/03/2015
Withdrawal Date06/16/2025
Product Code OZA 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CAMBRIDGE ISOTOPE LABORATORIES, INC. (CIL'S) AMENDED DRUG MASTER FILE (DMF) #11378 ON BEHALF OF OAPI'S PMA APPLICATION WHICH USES THE DRUG AS A COMPONENT OF THE BREATHTEK UBT FOR H. PYLORI KIT. THIS SUPPLEMENT REQUESTS THE REVIEW OF THE FOLLOWING CHANGES TO THE DRUG MASTER FILE:1. PROCESS CHANGE TO MANUFACTURING SCALE TO ADD 18KG PROCESS;2. UPDATE TO SPECIFICATIONS AND TEST METHODS FOR 13C-UREA;3. CHANGES IN QC TESTING LOCATIONS; AND 4. CHANGES IN MANUFACTURING LOCATIONS FOR 18KG PROCESS.
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