This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: PyloPlus UBT System
PMA Applicant: ARJ Medical Inc
Address: 209 State Street East, Oldsmar, FL 34677 US
Approval Date: February 18, 2020
Approval Letter: Approval Order

What is it?

The PyloPlus UBT System is a laboratory test used to detect an infection caused by Helicobacter pylori (H. pylori) bacteria in the stomach.

How does it work?

The system relies on measuring carbon dioxide. A person suspected of an H. pylori infection provides a breath sample by breathing into a breath collection bag to obtain a baseline breath. The person is then asked to swallow a drug mixture that contains urea labeled with a harmless radioactive carbon. Approximately 20 minutes after swallowing the drug mixture, the person provides another breath sample (test breath). The breath samples are analyzed by a trained health care professional and the results are provided to the prescribing physician. The system measures the samples and determines if the second (test) sample has a higher radioactive carbon dioxide level than the first (baseline) sample, it is a sign of an H. pylori infection.

When is it used?

The PyloPlus UBT System is used when a doctor suspects a person 18 years of age or older may be infected with H. pylori.

What will it accomplish?

Results of this test, in combination with a patient's medical history, may be used by the doctor to help determine if a person has been infected with H. pylori.

When should it not be used?

There are no reasons not to use the PyloPlus UBT System.

Additional information (including warnings, precautions, and adverse events):  

• Summary of Safety and Effectiveness Data (SSED)
• Labeling
• PMA Database Entry