PMA P050051S004
- Device
- ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S004
- Product code
- LOM
- Decision date
- 2009-07-23
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT AUSAB ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/ I 2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.ARCHITECT AUSAB REAGENT KIT ON ARCHITECT I 1000SR: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, LITHIUMHEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED FOR QUANTITATIVEMEASUREMENT OF ANTIBODY RESPONSE FOLLOWING HEPATITIS B VIRUS (HBV) VACCINATION,DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE LABORATORY DIAGNOSIS OF HBV DISEASEASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.ARCHITECT AUSAB CALIBRATORS ON ARCHITECT I 1000SR: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 ANYOTHER ANTI-HBS ASSAY.ARCHITECT AUSAB CONTROLS ON ARCHITECT I 1000SR:THE ARCHITECT AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THEARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THEPERFORMANCE OF THE ARCHITECT AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANYOTHER ANTI-HBS ASSAY.
Current openFDA PMA Record#
- Device
- ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2009-07-23
- Decision code
- APPR
- Date received
- 2009-02-12
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT AUSAB ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/ I 2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.ARCHITECT AUSAB REAGENT KIT ON ARCHITECT I 1000SR: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, LITHIUMHEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED FOR QUANTITATIVEMEASUREMENT OF ANTIBODY RESPONSE FOLLOWING HEPATITIS B VIRUS (HBV) VACCINATION,DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE LABORATORY DIAGNOSIS OF HBV DISEASEASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.ARCHITECT AUSAB CALIBRATORS ON ARCHITECT I 1000SR: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 ANYOTHER ANTI-HBS ASSAY.ARCHITECT AUSAB CONTROLS ON ARCHITECT I 1000SR:THE ARCHITECT AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THEARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THEPERFORMANCE OF THE ARCHITECT AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANYOTHER ANTI-HBS ASSAY.