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U.S. Department of Health and Human Services

Medical Devices

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IMMULITE® Anti-HBc IgM and IMMULITE® 2000 Anti-HBc IgM - P010053

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 IgM and IMMULITE® 2000 Anti-HBc IgM
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/p010053a.pdf

What is it? The products are laboratory tests that detect early antibodies associated with hepatitis B virus (HBV) infection. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV. IgM antibody to hepatitis B core antigen (anti-HBc IgM) is an early antibody that normally appears in an HBV infection. Along with other tests, this test is used to follow the course of an HBV infection. 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 antibodies. Hepatitis B core antigen is then added to this mixture which attaches to the coated antibody bead. If the patient is infected with HBV, the IgM antibodies specific for this antigen are captured on the bead. Chemicals are then added to produce a light reaction. This light reaction is measured by the analyzer. The amount of light produced above a certain level indicates the presence of antibodies (anti-HBc IgM) in the blood.

When is it used? To determine whether a person is infected or has been recently infected with the HBV.

What will it accomplish? The test helps to determine the stage of infection and what treatment may be needed. Depending of the results of this test and other testing the doctor may recommend anti-viral treatment.

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=p010053