Medical Devices

Abbott RealTime HCV Genotype II; Abbott RealTime HCV Genotype II Control Kit; and Uracil-N-Glycosylase (UNG) - P120012

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.

Image of Abbott RealTime HCV Genotype II; Abbott RealTime HCV Genotype II Control Kit; Uracil-N-Glycosylase (UNG)

Product Name:
Abbott RealTime HCV Genotype II
Abbott RealTime HCV Genotype II Control Kit
Uracil-N-Glycosylase (UNG)

PMA Applicant: Abbott Molecular Inc.
Address: 1300 E. Touhy Ave, Des Plaines IL 60018
Approval Date: June 20, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120012a.pdf

What is it? The Abbott RealTime HCV Genotype II is a laboratory test that can determine certain genetic types of the hepatitis C virus (HCV) providing results about what type of HCV a person is carrying.

HCV is the most common chronic blood-borne infection in the United States and the leading cause of liver transplants. Untreated chronic HCV infections may lead to liver cancer, severe liver damage, and liver failure.

How does it work? A patient’s blood sample is taken. The test extracts genetic material from inside the HCV virus. The test then produces multiple identical copies (amplification) of specific segments of the extracted genetic material to help identify the unique genotypes. It uses fluorescence to detect the amplified signal for each genotype in the laboratory.

When is it used? The Abbott RealTime HCV Genotype II assay is used in individuals known to be chronically infected with HCV. It can differentiate HCV genotypes 1, 1a, 1b, 2, 3, 4, and 5 in a sample of human blood plasma or serum from an individual chronically infected with HCV.

What will it accomplish? The particular type of HCV is an important factor, together with other clinical factors, in helping determine the appropriate type of therapy for patients with chronic HCV infections. Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes.

When should it not be used? The Abbott RealTime HCV Genotype II test should not be used as a diagnostic test or as a screening test for the presence of HCV genetic material in donated blood, blood products, or tissue donors.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available.

Page Last Updated: 06/17/2014
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