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U.S. Department of Health and Human Services

Medical Devices

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AxSYM® AUSAB® Reagent Kit, Calibrator and Controls - P060003

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: AxSYM® AUSAB® Reagent Kit, AxSYM® AUSAB® Calibrators, AxSYM® AUSAB® Controls
PMA Applicant: Abbott Laboratories
Address: Abbott Laboratories, Diagnostics Division, 100 Abbott Park Road, Abbott Park, IL 60064-6092
Approval Date: August 7, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060003a.pdf

What is it? The device is a lab test used to determine whether a person is, or has been, infected with the hepatitis B virus (HBV), or to determine whether a patient needs to be vaccinated with HBV vaccine.

AxSYM ® 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 AxSYM ® System.

How does it work?

  • Patient blood serum/plasma sample and recombinant HBsAg (rHBsAg) coated paramagnetic microparticles are combined.
  • If there is anti-HBs in the blood, antibody-antigen complexes will form.
  • These antibody-antigen complexes are further reacted with acridinium-labeled rHBsAg conjugate and another reagent to produce light. 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. The quality Control materials help to monitor the performance of the assay.

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? Test results help determine whether a patient should be advised to receive the hepatitis B virus vaccine. Or results may help to show the stage of HBV infection. Depending on the stage of infection, doctors may recommend appropriate treatment.

When should it not be used? This lab test should not be used if it is not ordered by a physician. This test is a prescription device. This test has not been FDA licensed for screening blood donors. There are no other known patient exclusions.

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=p060003