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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
Classification Nametest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantOTSUKA AMERICA PHARMACEUTICAL, INC.
PMA NumberP100025
Date Received06/22/2010
Decision Date02/22/2012
Product Code
OZA[ Registered Establishments with OZA ]
Docket Number 12M-0207
Notice Date 03/07/2012
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 in adult 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 for monitoring 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 for administration by a health care professional, as prescribed by a physician.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
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