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: IMMULITE® Anti-HBc and IMMULITE® 2000 Anti-HBc
Manufacturer: Diagnostic Products Corporation (DPC)
Address: 5700 West 96th Street, Los Angeles, California 90045
Approval Date: July 24, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p010051a.pdf
What is it? The product is a laboratory test that detect antibodies associated with hepatitis B virus (HBV) infection (anti-hepatitis B surface antigen), and can determine a person’s immunity to the HBV. The product does this by measuring the level of antibodies to HBV. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV. These antibodies, which were formed either during a previous HBV infection or because of receiving the HBV vaccine, help protect against future infections with HBV. The test can be run on the Immulite analyzer and the Immulite 2000 analyzer.
How does it work? A sample of the patient’s blood comes into contact with a plastic bead coated with HBV antigen (hepatitis B surface antigen). If the patient was, in the past, infected with HBV or has received the HBV vaccine, antibodies specific for this antigen are captured on the bead. Labeled antibodies are then added to this mixture, and they attach to the antigen-antibody coated bead. Chemicals are then added which produce a light reaction. This light reaction is measured by the analyzer. The amount of light produced above a certain level shows the level of antibodies (anti-HBsAg) in the blood indicated the individual may be immune to HBV infection.
When is it used? To determine whether a person is immune to the hepatitis B virus.
What will it accomplish? Aids the physician in deciding if a person should receive the hepatitis B vaccine.
When should it not be used? For testing newborns and young children.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010051