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  1. Recently-Approved Devices

PyloPlus UBT System - P170022/S003

Picture of the PyloPlus UBT System - P170022

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: January 11, 2024
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.

The PyloPlus UBT System is used when a doctor suspects a person 3 years of age or older may be infected with H. pylori.

A person suspected of an H. pylori infection provides a breath sample by breathing into a breath collection bag. The person then swallows a drug mixture that contains a harmless radioactive carbon. Approximately 20 minutes after swallowing the drug mixture, the person provides another breath sample. The breath samples are tested by trained health care professionals as prescribed by a doctor. If the second sample has higher radioactive carbon dioxide level than the first sample, it is a sign of an H. pylori infection.

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. Clinical studies were conducted to support the use of the PyloPlus UBT System in both adult and pediatric populations.

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

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