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U.S. Department of Health and Human Services

Medical Devices

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ARCHITECT® HBsAg Assay - P060007

photo of ARCHITECT® HBsAg Assay - P060007This 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 ® HBsAg Reagent Kit
ARCHITECT ® HBsAg Calibrators
ARCHITECT ® HBsAg Controls
ARCHITECT ® HBsAg Confirmatory Reagent Kit
ARCHITECT ® HBsAg Confirmatory Manual Diluent

PMA Applicant: Abbott Laboratories
Address: Abbott Laboratories, Diagnostics Division, 100 Abbott Park Road, Abbott Park. IL 60064-3502
Approval Date: September 7, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060007a.pdf

What is it? These reagents are used with the Abbott ARCHITECT ® Instrument System to identify certain virus proteins associated with hepatitis B virus (HBV). If these virus proteins are present, then the patient is likely to be infected with HBV.

How does it work?

  • A sample of the patient's blood is placed into reaction wells containing microparticles coated with antibodies to HBV.
  • If the blood sample contains HBV proteins, they will bind to the microparticles in the reaction wells.
  • This reaction is detected by another substance that produces light, which is then measured to determine the presence of HBV in the blood.
  • If this first test is positive, the patient's blood is retested to confirm the presence of HBV.

When is it used? This test is used to confirm whether or not a person is infected with HBV.

What will it accomplish? It can be used for testing pediatrics and pregnant women to see if the child may be at high risk for HBV infection.

When should it not be used? This test should not be used for screening blood donors because FDA has not licensed it for this purpose .

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=p060007