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U.S. Department of Health and Human Services

Medical Devices

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COBAS TaqMan HBV Test For Use With The High Pure System - P050028

photo of COBAS TaqMan HBV Test For Use With The High Pure System - P050028This 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.


Product Name: COBAS TaqMan HBV Test For Use With The High Pure System
PMA Applicant: Roche Molecular Systems, Inc. (RMS)
Address: Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588
Approval Date: September 4, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050028a.pdf

What is it? The COBAS Taqman HBV Test For Use With The High Pure System is a laboratory test kit that measures the amount of hepatitis B viral DNA in the blood of an individual infected by the hepatitis B virus (HBV). Viral DNA (deoxyribonucleic acid) is the genetic material from the hepatitis B virus. The individual’s hepatitis B viral DNA load is measured before beginning treatment, and during treatment to assess an individual’s response to the treatment. This test is used with the Roche COBAS TaqMan 48 Analyzer for automated amplification and detection. The results from the COBAS TaqMan HBV Test must be interpreted within the context of all other relevant clinical and laboratory findings.

How does it work? A sample of a patient’s blood is obtained and sent to a clinical laboratory. Nucleic acid (DNA) is manually separated from the cells in the blood sample using the High Pure System. Separated DNA is mixed with the assay reagents and the resulting mixture put into the COBAS TaqMan 48 Analyzer. The COBAS TaqMan 48 Analyzer calculates the amount of HBV DNA in the patient’s blood based on the amount of produced light measured by the analyzer after completion of the reaction. Measurement of the amount of HBV DNA in the blood together with clinical presentation and other laboratory findings is used by physicians to help determine an individual’s response to treatment.

When is it used? This test is used together with other laboratory results and clinical information to evaluate the treatment of an individual infected with the hepatitis B virus.

What will it accomplish? Test results help determine an individual’s response to treatment and aid in the management of patients with HBV infection undergoing anti-viral therapy.

When should it not be used? This lab test should not be used if it is not ordered by a physician. The assay should not be used to determine if a person is infected with the hepatitis B virus or to determine the stage of HBV infection. It should not be used to screen blood or blood products for transfusion. And, it should not be used for prediction of the success of anti-viral treatment.

Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050028