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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 FOR THE ARCHITECT I2000SR ANALYZER
Generic NameKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Regulation Number866.6010
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
AP5N-2, DEPT. 09VB
ABBOTT PARK, IL 60064-3500
PMA NumberP820060
Supplement NumberS016
Date Received11/26/2002
Decision Date02/02/2004
Withdrawal Date 11/15/2013
Product Code LOJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF THE ABBOTT ARCHITECT AFP ASSAY ON THE ARCHITECT I2000SR ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT ARCHITECT AFP ASSAY FOR THE ARCHITECT I2000 ANALYZER AND IS INDICATED FOR THE FOLLOWING: 1) HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOSUS TESTICULAR CANCER. 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF 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.
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