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 Data (SSED) 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 Qualitative

ARCHITECT HBsAg Qualitative Confirmatory

ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent

ARCHITECT HBsAg Qualitative Calibrators

ARCHITECT HBsAg Qualitative Controls

PMA Applicant: Abbott Laboratories

Address: 100 Abbott Park Road, Dept. 09V6, Bldg. AP5 - 2, Abbott Park. IL 60064-6095

Approval Date: April 12, 2012

Approval Letter:

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 provide evidence of whether or not a person is infected with HBV.

What will it accomplish? It is used for testing children and adults for evidence of HBV infection. It is also used for testing pregnant women to find out if a newborn 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 Data and labeling are available online.