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-M, ARCHITECT® CORE-M Calibrators, and ARCHITECT® CORE-M Controls
PMA Applicant: Abbott Laboratories
Address: 100 Abbott Park Road, Abbott Park. IL 60064-6092
Approval Date: November 6, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060035a.pdf
What is it? The ARCHITECT ® CORE-M is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. ARCHITECT® CORE-M Reagent Kit, Calibrators, and Controls are used to detect antibodies associated with HBV infection. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV. Presence of the antibodies can help determine if the patient is currently or has previously been infected with HBV. This test can only be run on the ARCHITECT ® instrument.
How does it work?
- A sample of the patient’s blood is combined with anti-human IgM coated paramagnetic microparticles to form antibody-antigen complexes
- the anti-HBc specific IgM binds to the acridinium-labeled recombinant hepatitis B virus core antigen (rHBcAg) conjugate that is added in the second step
- These antibody-antigen complexes are further reacted with other substances to produce a light reaction.
- The amount of light produced is measured.
- With the help of Calibrators, a determination is made whether there is anti-HBc IgM in the patient’s blood.
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 may help a doctor determine:
- the stage of HBV infection
- an appropriate course of treatment, depending on the stage of HBV infection
When should it not be used? This lab test should not be used if it is not ordered by a physician. This test is a prescription device. This test has not been FDA licensed for screening blood donors. There are no other known patient exclusions.
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=p060035