Newly approved Medical device by US FDA

ARCHITECT® CORE Reagent Kit, Calibrator and Controls - P080023


Product Name: ARCHITECT® CORE Reagent Kit, ARCHITECT® CORE Calibrator, ARCHITECT® CORE Controls
PMA Applicant: Abbott Laboratories
Approval Date: April 10, 2009

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).

Working:

* 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.