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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
Generic NameTest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantMeridian Bioscience, Inc.
3471 River Hills Drive
Cincinnati, OH 45244
PMA NumberP100025
Date Received06/22/2010
Decision Date02/22/2012
Product Code OZA 
Docket Number 12M-0207
Notice Date 03/07/2012
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0. THE BREATHTEK UBT KIT IS CURRENTLY CLEARED FOR USE INADULT PATIENTS UNDER 510(K) PREMARKET NOTIFICATION, K014225, AND THE PRANACTIN-CITRIC IS APPROVED UNDER NDA 20-586/S-004. THIS DEVICE IS INDICATED FOR: THE BREATHTEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) IS INTENDED FOR USE IN THE QUALITATIVE DETECTION OF UREASE ASSOCIATED WITH H. PYLORI IN THE HUMAN STOMACH AND IS INDICATED AS AN AID IN THE INITIAL DIAGNOSIS AND POST-TREATMENT MONITORING OF H. PYLORI INFECTION IN ADULTS, AND PEDIATRIC PATIENTS 3 TO 17 YEARS OLD. THE TEST MAY BE USED FORMONITORING TREATMENT IF USED AT 4 WEEKS FOLLOWING COMPLETION OF THERAPY. FOR THESE PURPOSES, THE SYSTEM UTILIZES AN INFRARED SPECTROPHOTOMETER FOR THE MEASUREMENT OF THE RATIO OF 13CO2 TO 12CO2 IN BREATH SAMPLES, IN CLINICAL LABORATORIES AND POINT-OF-CARE SETTINGS. THE PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), PROVIDED AS A WEB-BASED CALCULATION PROGRAM, IS REQUIRED TO OBTAIN PEDIATRIC TEST RESULTS. THE BREATHTEK UBT KIT IS FORADMINISTRATION BY A HEALTH CARE PROFESSIONAL, AS PRESCRIBED BY A PHYSICIAN.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 
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