POCone-UBiT-IR300 Pediatric Comparison Study

Inclusion Criteria:

1. Male or female subject ages 3 to 1711/12 years.

2. Subject with upper gastrointestinal signs and symptoms (e.g., abdominal
pain/discomfort, bloating, nausea, or vomiting, etc.)

3. Subject and/or parent/legal guardian is capable of giving assent or consent.

4. Subject is able to complete the urea breath test by investigator's assessment.

Exclusion Criteria:

1. Subject is hypersensitive to mannitol, citric acid and/or aspartame.

2. Previous diagnosis of phenylketonuria (PKU.

3. Subject with difficulty swallowing or who may be at high risk for aspiration due to
medical or physical conditions.

4. Subjects with ongoing respiratory conditions or on bronchodilators that may
compromise the collection of breath samples.

5. Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney
diseases, etc.)

6. Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14
days prior to the testing.

7. Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole,
clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the
testing.

8. Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole,
lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14
days prior to the testing.

9. Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine,
cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the
testing.

10. Treatment for eradication of H pylori within 28 days before testing or retesting.

11. Participation in a drug or device study within 30 days of testing