- Device
- PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer
- Applicant
- Arj Medical, Inc.
- PMA number
- P170022
- Supplement
- S001
- Product code
- OZA
- Generic name
- Test, urea adult and pediatric (breath),
- Decision date
- 2022-11-30
- Decision code
- APPR
- Date received
- 2022-05-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer and is indicated for The PyloPlus UBT system. The device, as modified, 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.