This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: ARCHITECT® AUSAB® Reagent Kit, ARCHITECT® AUSAB® Calibrators, ARCHITECT® AUSAB® Controls
PMA Applicant: Abbott Laboratories
Address: Abbott Laboratories, Diagnostics Division, 100 Abbott Park Road, Abbott Park. IL 60064-6092
Approval Date: June 1, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050051a.pdf
What is it? The ARCHITECT® AUSAB® is a lab test used to determine if a person is, or has been, infected with the hepatitis B virus (HBV), or to determine if a patient needs to be vaccinated with HBV vaccine.
ARCHITECT ® AUSAB ® Reagent Kit, Calibrators, and Controls are used to detect antibodies associated with hepatitis B virus surface antigen (anti-HBs). Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV. This test is performed after vaccination against HBV or following an active infection. This test can only be run on the ARCHITECT ® i System.
How does it work?
- A sample of the patient’s blood is combined with recombinant HBsAg (rHBsAg) coated microparticles.
- If there are anti-HBs antibodies in the blood, antibody-antigen complexes will form.
- These antibody-antigen complexes are further reacted with other substances to produce a light reaction.
- The amount of light produced is measured.
- With the help of Calibrators, a determination is made whether there is anti-HBs in the patient’s blood.
When is it used? This lab test is used to determine if the person is, or has been, infected with HBV or to determine if a patient needs to be vaccinated with HBV vaccine.
What will it accomplish? Results of this lab test may help a doctor determine:
- whether a patient should be advised to receive HBV vaccine
- the stage of HBV infection
- an appropriate course of treatment, depending on the stage of HBV infection
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050051