Important Safety Information

Intended Use:

The BreathTek® UBT for Helicobacter pylori (H. pylori) Kit is intended for use in the qualitative detection of urease associated with
H. pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adult patients. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.

The BreathTek UBT Kit is for administration by a health care professional, as prescribed by a physician.

Warnings and Precautions:

  1. For in vitro diagnostic use only. The Pranactin®-Citric drug solution is taken orally as part of the diagnostic procedure.
  2. Phenylketonurics: Contains Phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.)
  3. Blood glucose: Use with caution in diabetic patients. Pranactin-Citric contains Aspartame.
  4. A negative result does not rule out the possibility of H. pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, retest with a new sample or an alternative method.
  5. Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori. Ingestion of these within
    2 weeks prior to performing the BreathTek UBT may give false negative results.
  6. A false positive test may occur due to urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii.
  7. Premature POST-DOSE breath collection time can lead to a false negative diagnosis for a patient with a marginally positive BreathTek UBT result.
  8. A false positive test could occur in patients who have achlorhydria.
  9. If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing, the solution should not be used.
  10. Hypersensitivity: Patients who are hypersensitive to mannitol, citric acid or Aspartame should avoid taking the solution as this drug solution contains these ingredients.
  11. Risk of Aspiration: Use with caution in patients with difficulty swallowing or who may be at high risk of aspiration due to medical or physical conditions.
  12. Pregnancy: No information is available on use of the drug solution during pregnancy.

Postmarketing Experience:

The following adverse events have been identified during postapproval use of BreathTek UBT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure: rash, burning sensation in the stomach, tingling in the skin, vomiting and diarrhea.

Limitations:

  1. The BreathTek UBT should not be used until 4 weeks or more after the end of treatment for the eradication of H. pylori as earlier post-treatment assessment may give false negative results.
  2. The performance characteristics for persons under the age of 18 have not been established for this test.
  3. The specimen integrity of breath samples and reference gases stored in breath bags under ambient conditions has not been determined beyond 7 days.
  4. A correlation between the number of H. pylori organisms in the stomach and the BreathTek UBT result has not been established.
  5. The predicate device (Meretek UBT) was standardized in asymptomatic healthy volunteers and subsequently validated in clinical trials limited to patients with documented duodenal ulcer disease.

Patient Preparation:

  1. Remind the patient that Pranactin-Citric contains phenylalanine (one of the protein components of Aspartame). Phenylketonurics restrict dietary phenylalanine.
  2. The patient should have fasted at least 1 hour before administering the BreathTek UBT.
  3. The patient should not have taken antimicrobials, proton pump inhibitors, or bismuth preparations within 2 weeks prior to administering the BreathTek UBT.

0510O-1038      August 2010