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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.
 
DeviceACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantBECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD M/S
W-110
BREA, CA 92822
PMA NumberP980041
Supplement NumberS008
Date Received04/10/2006
Decision Date05/16/2006
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 THE ACCESS AFP REAGENTS FOR USE ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS. THE ACCESS AFP ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR USE WITH THE ACCESS IMMUNOASSAY SYSTEMS FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANCER. 2) MATERNAL SERUM AND AMNIOTIC FLUID AT 15 TO 20 WEEKS GESTATION, TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (ONTD). TEST RESULTS, WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY, ARE SAFE AND EFFECTIVE AIDS IN THE DETECTION OF FETAL ONTD. THE ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY.
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