Abbott Architect Ausab

Approval order statement

APPROVAL FOR THE ARCHITECT AUSAB REAGENT KIT, WHICH IS INDICATED FOR: ARCHITECT AUSAB REAGENT KIT: THE ARCHITECT AUSAB ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED FOR QUANTITATIVE MEASUREMENT OF ANTIBODY RESPONSE FOLLOWING HEPATITIS B VIRUS (HBV) VACCINATION, DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. ARCHITECT AUSAB CALIBRATORS: THE ARCHITECT AUSAB CALIBRATORS ARE USED TO CALIBRATE THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT AUSAB CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS. ARCHITECT AUSAB CONTROLS: THE ARCHITECT AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.