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.
Product Name: ARCHITECT® CORE Reagent Kit, ARCHITECT® CORE Calibrator, ARCHITECT® CORE Controls
PMA Applicant: Abbott Laboratories
Address: Abbott Laboratories, Abbott Diagnostics Division, 100 and 200 Abbott Park Road, Abbott Park, IL 60064-3500
Approval Date: April 10, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080023a.pdf
What is it? The ARCHITECT ® CORE Reagent Kit , Calibrator, and Controls constitute a laboratory test used to detect antibodies (anti HBc) associated with the hepatitis B virus (HBV) core antigen. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV. The presence of the anti-HBc antibodies can help determine if a person is currently infected or has previously been infected with HBV. This test is designed for use on the ARCHITECT i Systems (i 2000 and i2000 SR).
How does it work?
- The ARCHITECT ® CORE Reagent Kit is a chemiluminescent microparticle immunoassay
- A sample of a person’s blood is combined with recombinant HBc Antigen (rHBcAg) coated paramagnetic microparticles
- If anti-HBc antibodies are present in the blood, they bind to the rHBcAg coated microparticles
- A labeled anti-human conjugate is added, producing a chemiluminescent reaction with the antibodies bound to the microparticles
- The amount of light produced can be measured by the system.
- The presence or absence of anti-HBc in the patient's blood is determined by comparison to an active calibration.
When is it used? This lab test is used to determine if the person is, or has been, infected with HBV.
What will it accomplish? Results of this lab test, in combination with other clinical results, may help a doctor determine:
- The stage of HBV infection
- An appropriate course of treatment, when used in conjunction with other laboratory tests indicating infection with the hepatitis B virus
When should it not be used? This lab test should not be used if it has not been ordered by a physician. This test is a prescription device. This test has not been FDA licensed for screening blood, plasma, tissue donors, or immunocompromised or immunosuppressed patients. There are no other known patient exclusions.
Additional information: The Summary of Safety and Effectiveness and Labeling will be available online