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New Device Approval

ADVIA Centaur® HBc IgM ReadyPack Reagents
ADVIA Centaur® HBc IgM Quality Control (Calibrator and Control) Materials - P030040

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: ADVIA Centaur® HBc IgM ReadyPack Reagents
ADVIA Centaur® HBc IgM ReadyPack Quality Control Materials
Applicant: Bayer HealthCare LLC
Address: 511 Benedict Avenue, Tarrytown, NY 10591-5097
Approval Date: August 6, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf3/p030040a.pdf

What is it? The reagent pack is a laboratory test that detects 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 during an HBV infection. Along with other tests for HBV infection, this test is used to follow the course of an HBV infection. The test can be run only on the ADVIA Centaur® Immunodiagnostic system.

The calibrator is a reagent that is used to set the analyzer so that it may distinguish between positive and negative results.

How does it work?

• A sample of the patient’s blood is placed into a container where it comes into contact with specific antibodies.
• An artificial hepatitis B core antigen (HBc) is then added to this mixture which may attach to the antibody coated container.
• If the patient is or recently has been infected with HBV, HBc antigen is captured.
• Chemicals are then added to produce a light reaction.
• This light reaction is measured by the analyzer.
• The amount of light produced indicates the presence of anti-HBc IgM in the blood sample.
• If this light level is above the threshold set by the calibrator the blood sample is considered to have IgM antibodies against HBc.

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

What will it accomplish? This 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? There are no contraindications for the use of this device.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf3/p030040.html

Other:

• Centers for Disease Control and Prevention FAQ on HBV:
  http://www.cdc.gov/ncidod/diseases/hepatitis/b/faqb.htm
• National Institutes of Health information on HBV:
  http://www.niddk.nih.gov/health/digest/pubs/hep/hepb/hepb.htm
• Hepatitis Foundation International online community for people with hepatitis:
  http://www.hepfi.org/

Updated October 28, 2004

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