Axsym, Ausab
FDA premarket approval P060003 · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval
- Applicant
- Abbott Laboratories, Inc.
- Received
- February 10, 2006
- Decision date
- August 7, 2006 (APWD)
- Supplements
- 12, latest December 5, 2012
- Product code
- LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
APPROVAL FOR THE AXSYM AUSAB ASSAY. THE DEVICE IS INDICATED FOR: AXSYM AUSAB REAGENT PACK IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN SODIUM HEPARIN). THE ASSAY IS USED FOR THE QUANTITATIVE MEASUREMENT OF ANTIBODY RESPONSE TO HEPATITIS B VIRUS (HBV) VACCINATION FOR THE DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. THE AXSYM AUSAB STANDARD CALIBRATORS ARE USED FOR THE CALIBRATION OF THE AXSYM SYSTEM WHEN THE SYSTEM IS USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE AXSYM AUSAB REAGENT PACK. THE PERFORMANCE OF THE AXSYM AUSAB STANDARD CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS. THE AXSYM AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE AXSYM SYSTEM (REAGENT, CALIBRATORS, AND INSTRUMENT) WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) WHEN USING THE AXSYM AUSAB REAGENT PACK. THE PERFORMANCE OF THE AXSYM AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.