Premarket Approval (PMA)

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.

• Device: PyloPlus UBT System
• Generic Name: Test, urea adult and pediatric (breath),
• Regulation Number: 866.3110
• Applicant: Arj Medical, Inc.; 209 State St. E.; Oldsmar, FL 34677
• PMA Number: P170022
• Date Received: 07/26/2017
• Decision Date: 02/18/2020
• Product Code: OZA
• Docket Number: 20M-0985
• Notice Date: 02/26/2020
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the PyloPlus UBT.The PyloPlus UBT system 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 of H. pylori infection in adults 18 years old and older. The PyloPlus UBT system consists of the PyloPlus UBT Kit and the PyloPlus UBT analyzer. The analyzer is an infrared Spectrometer used for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. The PyloPlus UBT system is for use by trained health care professionals as prescribed by a physician.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003 S005 S007 S008