You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to Identify a ll comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document, contact Freddie M. Poole at 301-796-5457 or by e-mail at

When final, this document will supersede Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter Pylori dated September 17, 1992.


U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of In Vitro Diagnostic Device Evaluation and Safety

Division of Microbiology Devices

Draft - Not for Implementation

Contains Nonbinding Recommendations


Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to to receive an electronic copy of the guidance or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1712 to identify the guidance you are requesting.

Use of endoscopic diagnostic tests to diagnose H. pylori infection

Pre-therapy DiagnosisPre-therapy Diagnosis
Test ResultPatient StatusTest ResultPatient Status
Three Tests Available
--+Not Infected--+Infected
-+-Not Infected-+-Infected
---Not Infected---Eradicated
Two Tests Available
-+N/ANot evaluable-+N/AInfected
--N/ANot infected--N/AEradicated
-N/A+Not evaluable*-N/A+Infected
-N/A-Not Infected-N/A-Eradciated
N/A+-Not evaluableN/A+-Infected
N/A-+Not evaluable*N/A-+Infected
N/A--Not infectedN/A--Eradicated
One Test Available
-N/AN/ANot evaluable-N/AN/ANot evaluable
N/AN/A+Not evaluable*N/AN/A+Infected
N/AN/A-Not evaluableN/AN/A-Not evaluable
N/A+N/ANot evaluableN/A+N/AInfected
N/A-N/ANot evaluableN/A-N/ANot evaluable

N/A - Indicates not evaluable or missing result

* - Patients with a single positive urease test at baseline may be more appropriately considered infected.