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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.
 
DeviceBREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
Classification Nametest, urea adult and pediatric (breath),
Generic Nametest, urea adult and pediatric (breath),
Regulation Number866.3110
Applicant
OTSUKA AMERICA PHARMACEUTICAL, INC.
2440 research blvd.
rockville, MD 20850
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
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 
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