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U.S. Department of Health and Human Services

Medical Devices

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IMMULITE® Anti-HBs and IMMULITE® 2000 Anti-HBs - P010052

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-HBs and IMMULITE® 2000 Anti-HBs 
Manufacturer:
Diagnostic Products Corporation (DPC)
Address:
5700 West 96th Street, Los Angeles, California 90045
Approval Date:
July 22, 2002
Approval Letter: 
http://www.accessdata.fda.gov/cdrh_docs/pdf2/p010052a.pdf

What is it? A laboratory test, used in the Immulite or Immulite 2000 analyzer, that indicates how immune a person is to hepatitis B virus (HBV), and provides information on the course of disease following hepatitis B infection. It does this by measuring the level of antibodies to hepatitis B surface antigen (anti-HBs) in a sample of blood. These antibodies, which were formed either during a previous hepatitis B infection or because of receiving the hepatitis B vaccine, help protect against future infections with hepatitis B.

How does it work? In the analyzer, a sample of the patient's blood comes into contact with a bead coated with an antigen from HBV. If the patient’s blood has anti-HBs, the antibodies to HBV stick to the antigens on the bead. The analyzer adds chemicals which produce a light reaction, and the light is measured. The amount of light shows the level of anti-HBs in the blood.

When is it used? The test is used to determine if the person is, or has been, infected with HBV or if the person was previously vaccinated for HBV.

What will it accomplish? Test results help doctors determine whether to advise their patients to get the HBV vaccine. Or results may help to show the stage of HBV infection. Depending on the stage of infection, doctors may recommend anti-viral treatment.

When should it not be used? There are no known patient exclusions.

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=p010052