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: Abbott AxSYM® HBsAg Assay, Abbott AxSYM® HBsAg Confirmatory Assay, and Abbott AxSYM® HBsAg Assay Controls.
PMA Applicant: Abbott Laboratories
Address: Abbott Diagnostic Division, 100 Abbott Park Road, Abbott Park, IL 60064-3500
Approval Date: June 1, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050049a.pdf
What is it? This device is a lab test used to confirm whether or not a person is infected with hepatitis B virus (HBV). The reagents are used with the Abbott AxSYM ® Instrument System to identify certain virus proteins associated with 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 detector antibodies and 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 and what will it accomplish? This lab test is used to confirm whether or not a person is infected with HBV. It can be used for testing neonates, pediatrics, and pregnant women to see if the child may be at high risk for HBV infection.
When should it not be used? This lab 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=p050049