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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.
 
DeviceABBOTT ARCHITECT AFP ASSAY
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantAbbott Laboratories
09V6 AP5-2N
100 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064
PMA NumberP120008
Date Received05/01/2012
Decision Date11/28/2012
Product Code LOK 
Docket Number 12M-1176
Notice Date 12/05/2012
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ARCHITECT AFP ASSAY, ARCHITECT AFP CALIBRATORS AND ARCHITECT AFP CONTROLS. THIS DEVICE IS INDICATED FOR:THE ARCHITECT AFP ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN:1) HUMAN SERUM OR PLASMA TO AID IN MONITORING DISEASE PROGRESSION DURING THE COURSE OF DISEASE AND TREATMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER; AND 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD. THE ARCHITECT AFP CALIBRATORS ARE FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID. THE PERFORMANCE OF THE ARCHITECT AFP CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER AFP ASSAYS. THE ARCHITECT AFP CONTROLS ARE FOR THE ESTIMATION OF TEST PRECISION AND THE DETECTION OF SYSTEMATIC ANALYTICAL DEVIATIONS OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID. THE PERFORMANCE OF THE ARCHITECT AFP CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER AFP ASSAYS.
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 
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