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U.S. Department of Health and Human Services

Medical Devices

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The BreathTek UBT H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0 - P100025

Two boxes of the BreathTek UBT H. pylori Test.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 (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: The BreathTek UBT H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0
PMA Applicant: Otsuka America Pharmaceutical, Inc.
Address: 2440 Research Boulevard, Rockville, MD 20850
Approval Date: February 22, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100025a.pdf

What is it? The BreathTek UBT H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0 is a combination product which contains synthetic urea, a drug solution a patient must swallow, and a device component. This is a non-invasive urea breath test to detect current H. pylori and to diagnose and monitor H. pylori infection in pediatric patients 3 to 17 years old. The test was previously cleared for use in adult populations and is now approved for the pediatric population.

Additionally, the approval for the pediatric population provides a Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) as a web-based aid to calculate pediatric test results.

How does it work? The test contains a naturally occurring carbon isotope which is swallowed by the patient. If H. pylori are present in the stomach, the enzyme breaks down the product releasing carbon dioxide. This carbon dioxide is absorbed into the blood and then exhaled in the breath. The device component measures the difference between the ratios of carbon dioxide values before and after administration of the drug solution. If the ratio is the same, the test result is negative.

When is it used? This test is used for people with signs and symptoms of gastrointestinal conditions such as chronic gastritis or peptic ulcer disease. It is also used for patients who are at risk of H. pylori infection.

What will it accomplish? The test result is used in combination with other clinical information to aid in the diagnosis of individuals with signs or symptoms of H. pylori infection.

When should it not be used? The test should not be used in children under 3 years of age. It should only be used when prescribed by a physician.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

Other Resources: