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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 ARCHITECT AFP
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Ap5n-2, Dept. 09vb
Abbott Park, IL 60064
PMA NumberP820060
Supplement NumberS023
Date Received10/03/2007
Decision Date05/21/2008
Withdrawal Date11/15/2013
Product Code LOK 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) CREATION OF AFP WHO PRIMARY CALIBRATORS AND CONTROLS; 2) ASSAY SOFTWARE CHANGES: A) VOLUME OF SAMPLE IN THE PIPETTING PROTOCOL; B) DILUTION OF SPECIMEN IN THE AUTOMATED DILUTION PROTOCOLS; AND C) DILUTION PARAMETERS; 3) MANUAL DILUENT CHANGE; AND 4) NEW CONTROL CONCENTRATIONS.
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