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 Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc 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/p030024a.pdf
What is it? The reagent pack is a laboratory test that detects early and late 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. This test is used along with other HBV tests to monitor the course of an HBV infection. This test can only be run 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 in a container with hepatitis B core antigen attached to it.
- If the patient is or recently has been infected with HBV, antibodies will attach to the antigen.
- Another antibody that has a chemical attached is added to the container.
- 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 or absence of HBc antibodies in the blood sample.
- If this light level is below the threshold set by the calibrator the blood sample is considered to have the antibodies.
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 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=p030024