Testing for biotin interference in in vitro diagnostic devices

Testing for biotin interference in in vitro diagnostic devices

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, October 2020
Language(s):
English
Format:
Text
Subject(s):
Avidin -- antagonists & inhibitors
Biotin -- antagonists & inhibitors
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
The Food the Drug Administration (FDA or we) is providing recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). This guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians. The recommendations apply to IVDs, including devices that are licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) and used in donor screening, that use biotin technology. This guidance finalizes the draft guidance of the same title dated June 2019.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (i, 4 pages)).
NLM Unique ID:
9918231297106676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918231297106676