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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABBOTT AFP-EIA
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
AP5N-2, DEPT. 09VB
ABBOTT PARK, IL 60064-3500
PMA NumberP820060
Supplement NumberS024
Date Received11/20/2009
Decision Date02/26/2010
Withdrawal Date 11/15/2013
Product Code LOK 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES IN SOFTWARE THAT AFFECTED PATIENT RESULTS REPORTING FOLLOWING AUTOMATED DILUTION. THE LOW CONCENTRATION LIMIT FLAG FOR THE 1:101 AUTOMATED DILUTION PROTOCOL WITHIN THE AXSYM AFP ASSAY FILE WAS CHANGED FROM 0 NG/ML ON AXSYM CANCER ASSAY DISK VERSION 6, LN 3D50-06. THE CHANGE IN QUESTION MANDATES THAT PATIENT RESULTS ARE FLAGGED, FOLLOWING AUTO-DILUTION, WHEN THE CALCULATED VALUES OF THE UNDILUTED SAMPLE FALL BELOW 40.40 NG/ML AND THE MEASURED VALUE OF THE DILUTED SAMPLE FALLS BELOW 0.40 NG/ML.
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