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.
| Device | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 |
| Classification Name | Test, Urea Adult And Pediatric (breath), |
| Generic Name | Test, Urea Adult And Pediatric (breath), |
| Applicant | OTSUKA AMERICA PHARMACEUTICAL, INC. |
| Date Received | 2010-06-22 |
| Decision Date | 2012-02-22 |
| Notice Date | 2012-03-07 |
| PMA | P100025 |
| Supplement | S |
| Product Code | OZA |
| Docket Number | 12M-0207 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | OTSUKA AMERICA PHARMACEUTICAL, INC. 2440 Research Blvd. rockville, MD 20850 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100025 | | Original Filing |
| S014 |
2019-08-12 |
Normal 180 Day Track No User Fee |
| S013 |
2018-04-20 |
30-day Notice |
| S012 |
2017-01-09 |
Real-time Process |
| S011 |
2016-12-06 |
30-day Notice |
| S010 |
2015-09-15 |
Normal 180 Day Track |
| S009 |
2015-07-16 |
Normal 180 Day Track |
| S008 |
2015-01-13 |
Normal 180 Day Track |
| S007 |
2014-08-08 |
Normal 180 Day Track |
| S006 |
2014-01-22 |
Special (immediate Track) |
| S005 |
2013-06-28 |
Normal 180 Day Track |
| S004 |
2013-02-01 |
Normal 180 Day Track |
| S003 |
2012-10-12 |
Special (immediate Track) |
| S002 |
2012-08-31 |
Normal 180 Day Track No User Fee |
| S001 |
2012-03-19 |
Normal 180 Day Track |
NIH GUDID Devices