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: ARCHITECT® Anti-HCV, ARCHITECT Anti-HCV Calibrator, ARCHITECT Anti-HCV Controls
PMA Applicant: Abbott Laboratories
Address: Abbott Park, Illinois
Approval Date: June 7, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050042a.pdf
What is it? This device is a lab test used to help diagnose people that may be infected with hepatitis C virus (HCV).
How does it work?
- A sample of the patient’s blood serum is placed into wells coated with HCV antigen (proteins from HCV). If there is anti-HCV in the blood, it sticks to the antigen.
- The wells are washed to remove excess blood serum.
- Chemicals that cause a fluorescent light reaction (Reagent Pack solutions) are then added to the wells. If there are antibodies attached to the antigens, they react with the Reagent Pack solutions to produce light.
- The amount of light produced is measured and shows the presence anti-HCV in the patient’s blood serum.
When is it used? This is the initial laboratory test used for people who might be infected with hepatitis C virus.
What will it accomplish? The assay may be used in conjunction with other blood serum tests and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection.
When should it not be used? This test should not be used to make a final diagnosis of infection with HCV. If this test is positive, more tests will be required to determine if the person is infected. This test should not be used for screening blood donors, because it has not been proven effective for this purpose. It should be used only when prescribed by a physician.
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=p050042