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U.S. Department of Health and Human Services

Medical Devices

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Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the E170 MODULAR ANALYTICS - P100031

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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Photo of Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc for use on the E170 MODULAR ANALYTICSProduct Name: Elecsys® Anti-HBc Immunoassay Elecsys® PreciControl Anti-HBc for use on the E170 MODULAR ANALYTICS
Manufacturer: Roche Diagnostics
Address: 9115 Hague Road, Indianapolis, IN 46256 USA
Approval Date: June 22, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/
pdf10/p100031a.pdf

What is it? The Elecsys® Anti-HBc Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of these specific antibodies against the hepatitis B core antigen can help determine if a person is currently infected or has previously been infected with HBV. This test is designed for use on the E170 MODULAR ANALYITICS analyzer, which runs the assay and analyzes the results.

How does it work? A person's blood sample is added to a tube (vial) with the test chemicals. If there are antibodies to the hepatitis B core antigen in the blood, they attach to special microparticles to affect the production of a light signal. The light signal is measured by the E170 MODULAR ANALYITICS analyzer. The Elecsys® PreciControl Anti-HBc is used as a quality control to ensure that the test is working properly.

When is it used? The test result is used in combination with other clinical information and blood tests to aid in the diagnosis of individuals with signs and symptoms of hepatitis B, or in individuals at risk for hepatitis B infection.

What will it accomplish? Results of this lab test, in combination with other clinical information and laboratory blood tests, may be used by the clinician to aid in the diagnosis of patients with the symptoms of hepatitis B or who may be at risk for HBV infection.

When should it not be used? This test should not be used to determine the final diagnosis of HBV infection or to determine the stage of infection. This test has not been FDA-licensed for screening blood, plasma, tissue donors, or immunocompromised or immunosuppressed persons or for testing people under the age of 21 years.

Additional Information: Summary of Safety and Effectiveness and labeling are available online.

Other Resources: