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: AxSYM CORE™ 2.0 and AxSYM CORE™ 2.0 Controls
PMA Applicant: Abbott Laboratories
Address: Abbott Laboratories, Diagnostics Division, 100 Abbott Park Road, Abbott Park. IL 60064-6092
Approval Date: September 8, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060012a.pdf
What is it? The AxSYM CORE™ 2.0 is a lab test used to detect antibodies associated with hepatitis B (HBV) infection.
AxSYM CORE™ 2.0 Reagent Kit 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 AxSYM instrument.
How does it work?
- A sample of the patient’s blood is combined with recombinant HBcAg (rHBsAg) coated microparticles.
- Anti HBc in the patient sample blocks the binding of the anti HBc (human):alkaline phosphatase conjugate to the rHBcAg coated on the microparticles.
- The substrate (MUP) is added and the fluorescent product is measured by the MEIA optical assembly on the AxSYM System.
- The presence or absence of anti-HBc in the sample is determined by comparing the rate of formation of fluorescent product (S) to the cutoff rate (CO) calculated from the Index 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 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=p060012