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® HBsAg and IMMULITE® 2000 HBsAg and Confirmatory Kit
Manufacturer: Diagnostic Products Corporation (DPC)
Address: 5700 West 96th Street, Los Angeles, California 90045
Approval Date: July 26, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p010050a.pdf
What is it? These products are laboratory tests that detect hepatitis B surface antigen (HBsAg) associated with hepatitis B virus (HBV) infection. Testing is performed on a blood sample. A positive test result implies that the individual blood may contain HBV, this initial result must be confirmed using the Confirmatory Kit. If the positive result is confirmed by the Confirmatory Kit the individual is infected with HBV or has recently received the HBV vaccine. The tests are 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 bead coated with antibodies. If the patient is infected with HBV, the HBV antigen that is found in the patient’s blood is captured by the antibody-coated bead. Chemicals are then added which produces a light reaction. This light reaction is measured by the analyzer. The amount of light produced above a certain level shows that HBsAg may be present in the blood. If the initial test is positive the blood sample is retested with the Confirmatory Kit to confirm the presence of HBsAg.
When is it used? To determine whether a person is or is not infected by HBV.
What will it accomplish? The test helps to determine if an individual is or is not infected by HBV. Depending on the result of the test and other factors, the doctor may recommend anti-viral treatment.
When should it not be used? For the screening of blood donors, testing infants, and testing 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=p010050