Architect Hbsag Reagent Kit, Calibrators, Controls, Confirmatory Reagent Kit, Confirmatory Manual Diluent

Approval order statement

APPROVAL FOR THE ARCHITECT HBSAG REAGENTS, ARCHITECT HBSAG CALIBRATORS, ARCHITECT HBSAG CONTROLS, ARCHITECT HBSAG CONFIRMATORY REAGENTS, AND ARCHITECT HBSAG CONFIRMATORY MANUAL DILUENT. THE ARCHITECT HBSAG ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA). THE ASSAY MAY ALSO BE USED TO SCREEN FOR HBV INFECTION IN PREGNANT FEMALES TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION. THE ARCHITECT HBSAG CALIBRATORS ARE USED FOR CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) USING THE ARCHITECT HBSAG AND HBSAG CONFIRMATORY REAGENT KITS. THE PERFORMANCE OF THE ARCHITECT HBSAG CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG ASSAYS. (CONTINUED...)