Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064 |
PMA Number | P080023 |
Date Received | 08/28/2008 |
Decision Date | 04/10/2009 |
Product Code |
LOM |
Docket Number | 09M-0244 |
Notice Date | 05/27/2009 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS. THESE DEVICES ARE INDICATED FOR:ARCHITECT CORE REAGENT KIT:THE ARCHITECT CORE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY(CMIA) FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B COREANTIGEN (ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA,LITHIUM HEPARIN, SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED AS AN AID IN THE DIAGNOSIS OF ACUTE, CHRONIC, OR RESOLVED HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.ARCHITECT CORE CALIBRATOR:THE ARCHITECT CORE CALIBRATOR IS USED FOR THE CALIBRATION OF THE ARCHITECT ISYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TOHEPATITIS B CORE ANTIGEN (ANTI-HBC) WITH THE ARCHITECT CORE REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE CALIBRATOR HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC ASSAYS.ARCHITECT CORE CONTROLS:THE ARCHITECT CORE CONTROLS ARC USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) WITH THE ARCHITECT CORE REAGENT KIT. THEPERFORMANCE OF THE ARCHITECT CORE CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHERANTI-HBC ASSAYS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 |
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