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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantABBOTT LABORATORIES INC
100 ABBOTT PARK ROAD
AP5N-2, DEPT 09VB
ABBOTT PARK, IL 60064
PMA NumberP050042
Date Received11/23/2005
Decision Date06/07/2006
Reclassified Date 12/22/2021
Product Code MZO 
Docket Number 06M-0389
Notice Date 09/26/2006
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ABBOTT ARCHITECT ANTI-HCV. THIS DEVICE IS INDICATED FOR: THE ARCHITECT ANTI-HCV ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN). ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HCV (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE ARCHITECT ANTI-HCV CALIBRATOR IS USED FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN). THE ARCHITECT ANTI-HCV CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE ARCHITECT I SYSTEM WITH THE ARCHITECT ANTI-HCV REAGENT KIT. REFER TO THE ARCHITECT ANTI-HCV ASSAY REAGENT PACKAGE INSERT FOR THE FULL LISTING OF INFORMATION REGARDING THE ASSAY. THE ARCHITECT ANTI-HCV CONTROLS ARE USED TO PROVIDE AN ESTIMATION OF TEST PRECISION AND TO DETECT SYSTEMATIC ANALYTICAL DEVIATIONS OF THE ARCHITECT I SYSTEM (REAGENTS, CALIBRATOR, AND INSTRUMENT (WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN). THE ARCHITECT ANTI-HCV CONTROLS HAVE BEEN VALIDATED FOR USE ONLY ON THE ARCHITECT I SYSTEM WITH THE ARCHITECT ANTI-HCV REAGENT KIT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S046 S047 
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