Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• 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
• Supplement Number: S003
• Date Received: 05/23/2023
• Decision Date: 01/11/2024
• Product Code: OZA
• Docket Number: 24M-0280
• Notice Date: 01/12/2024
• Advisory Committee: Microbiology
• Clinical Trials: NCT05276557
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the PyloPlus® UBT System.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 and post treatment monitoring of H. pylori infection in adults and pediatric patients ages 3-17 years old. 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