Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori
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draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 http://www.regulations.gov. 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 Freddie.Poole@fda.hhs.gov.
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
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Draft - Not for Implementation Contains Nonbinding Recommendations
Contains Nonbinding Recommendations
Additional copies are available from the Internet. You may also send an e-mail request to firstname.lastname@example.org 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 Diagnosis||Pre-therapy Diagnosis|
|Test Result||Patient Status||Test Result||Patient Status|
|Three Tests Available|
|Two Tests Available|
|One Test Available|
|-||N/A||N/A||Not evaluable||-||N/A||N/A||Not evaluable|
|N/A||N/A||-||Not evaluable||N/A||N/A||-||Not evaluable|
|N/A||-||N/A||Not evaluable||N/A||-||N/A||Not evaluable|
N/A - Indicates not evaluable or missing result
* - Patients with a single positive urease test at baseline may be more appropriately considered infected.