PyloPlus® UBT System
FDA premarket approval P170022/S003 · decided 2024-01-11
Approval details
- PMA number
- P170022
- Supplement
- S003
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PyloPlus® UBT System
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Arj Medical, Inc.
- Date received
- 2023-05-23
- Decision date
- 2024-01-11
- Days to decision
- 233 days
- Decision code
- APPR
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Oldsmar, FL
- 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 13CO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| URITEST 50 AND URITEST 500 URINE ANALYZER (K091472) | Arj Medical, Inc. | 2010-04-27 |
| URITEST 10 URINALYSIS REAGENT STRIPS (K052719) | Arj Medical, Inc. | 2006-12-05 |
| PYLO-PLUS (K052708) | Arj Medical, Inc. | 2006-05-01 |