FDAnews Device Daily Bulletin

FDA APPROVES ABBOTT'S ARCHITECT AUSAB REAGENT KIT, CALIBRATORS AND CONTROLS

June 15, 2006
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The FDA's Center for Devices and Radiological Health (CDRH) granted pre-market approval (PMA) for Abbott's Architect Ausab Reagent Kit, Architect Ausab Calibrators, and Architect Ausab Controls.

The Architect Ausab is a lab test used to determine if a person is, or has been, infected with the hepatitis B virus (HBV), or to determine if a patient needs to be vaccinated with the HBV vaccine. The reagent kit, calibrators and controls are used to detect antibodies associated with hepatitis B virus surface antigens (anti-HBs).

Results of the test may help a doctor determine whether a patient should be advised to receive HBV vaccine and an appropriate course of treatment, depending on the stage of HBV infection.

The FDA's approval letter may be accessed at http://www.fda.gov/cdrh/pdf5/p050051a.pdf (http://www.fda.gov/cdrh/pdf5/p050051a.pdf). The summary of safety and effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf5/p050051.html (http://www.fda.gov/cdrh/pdf5/p050051.html)