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U.S. Department of Health and Human Services

Medical Devices

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COBAS AMPLICOR™ Hepatitis C Virus (HCV) Test, version 2.0 (v2.0) P000012

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: COBAS AMPLICOR ™Hepatitis C Virus (HCV) Test, version 2.0 (v2.0)
Manufacturer: Roche Molecular Systems, Inc
Address: 4300 Hacienda Dr, Pleasanton CA 94588-2722
Approval Date: July 3, 2001
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p000012a.pdf

What is it? The COBAS AMPLICOR™ HCV Test, v2.0 is a laboratory test for determining whether a person is actively infected with hepatitis C virus (HCV). HCV chronically infects several million Americans and causes hepatitis C and other liver diseases in many people.

How does it work? The COBAS AMPLICOR™ HCV Test, v2.0 takes genetic material from inside viruses in the patient's blood and uses enzymes to produce enough HCV genetic material for detection in the laboratory.

When is it used ? The COBAS AMPLICOR™ HCV Test, v2.0 is used for patients who are suspected to be actively infected with HCV because they have liver disease and their blood contains antibodies to HCV. The test will determine whether they are actively infected or not.

What will it accomplish? A positive COBAS AMPLICOR ™ HCV Test, v2.0 result indicates that HCV is reproducing itself in the liver and is thus evidence of active HCV infection. However, a negative test result does not rule out the possibility of active HCV infection.

When should it not be used? The COBAS AMPLICOR ™HCV Test, v2.0 should not be used:

  • On patients who do not have antibodies to HCV.
  • As the sole test for determining whether a patient is actively infected with HCV. (All COBAS AMPLICOR™ HCV Test, v2.0 results should be interpreted along with additional clinical and laboratory findings.)
  • For distinguishing between acute infection (less than six months duration) and chronic infection,
  • For determining whether a patient has liver disease,
  • For screening blood, plasma, or tissue donors, or
  • To eliminate the possibility of active HCV infection. (Caution should be used when interpreting a negative COBAS AMPLICOR™ HCV Test, v2.0 result.)

Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p000012

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