Description
Blood establishments are required under 21 CFR 610.40(a)(3) and (b) to test donations of human blood and blood components for hepatitis B virus using approved screening tests that are adequate and appropriate for this purpose. One test used to detect the presence of hepatitis B infection is the hepatitis B surface antigen (HBsAg) test.
Scope & Applicability
Product Classes
3Blood component intended for further manufacture
Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Blood component subject to the recommendations in this guidance
Stakeholders
3FDA advisory body discussing malaria testing strategies
Responsible for declaring acceptable market names on labels.
Entities that collect blood and blood components and are the primary audience for this guidance.
Regulatory Context
Attributes
2A negative test result in a screening assay.
Test result status indicating presence of a marker
Identified Hazards
Hazards
1Risk that regulations aim to prevent
Related CFR Sections (2)
- 21CFR610.40§ 610.40 Test requirements.
(a) Human blood and blood components. Except as specified in paragraphs (c) and (d) of this section, you, an establishment that collects blood and blood components for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medicalRead full regulation →
- 21CFR610.44§ 610.44 Use of reference panels by manufacturers of test kits.
(a) When available and appropriate to verify acceptable sensitivity and specificity, you, a manufacturer of test kits, must use a reference panel you obtain from FDA or from an FDA designated source to test lots of the following products. You must test each lot of the following products, unless FDA Read full regulation →
See Also (8)
- Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) (Status: Final)
- Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies: Guidance for Industry (Status: Final)
- Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff (Status: Final)
- Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc): Guidance for Industry (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus: Final Guidance for Industry (Status: Final)
- Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components: Guidance for Industry (Status: Final)