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U.S. Department of Health and Human Services

Medical Devices

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Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator - P030026

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: VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator
Applicant: Ortho-Clinical Diagnostics, Inc.
Address: 100 Indigo Creek Drive
Rochester, NY 14626
Approval Date: March 4, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030026a.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. This test can be run only on the VITROS ECi 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 with specific antibodies attached to it.
  • An artificial hepatitis B core antigen (HBc) is added.
  • If the patient is or has recently been infected with HBV, HBc antigen is captured by the antibodies.
  • Chemicals are added to produce a light reaction.
  • The light reaction is measured by the analyzer.
  • The amount of light produced indicates the presence of anti-HBc IgM antibodies in the blood sample.
  • If the 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 recently been infected with the HBV.

What will it accomplish? This test helps to determine the stage of HBV 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 this device.

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=p030026