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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 ANALYZER
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 NumberS006
Date Received07/29/2004
Decision Date08/04/2004
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 OF THE ADDITION OF AN ASSAY PROTOCOL FILE TO THE ASSAY SOFTWARE OF THE ACCESS AFP REAGENT FOR ON-BOARD SYSTEM AUTO-DILUTION OF HUMAN SERUM AND AMNIOTIC FLUID SAMPLES FOR ALL ACCESS IMMUNOASSAY ANLAYZERS (ACCESS, ACCESS 2, SYNCHRON LXI 725 AND UNICEL DXI 800). THE ACCESS AFP ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE 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 TO20 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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