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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.
 
DeviceAUTODELFIA XPRESS HAFP TEST SYSTEM
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantPerkinElmer, Inc.
940 Winter Street
Waltham, MA 02451
PMA NumberP970037
Supplement NumberS003
Date Received03/01/2010
Decision Date01/12/2011
Product Code LOK 
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 TO EXTEND THE AUTODELFIA HAFP KIT ONTO THE DELFIA XPRESS INSTRUMENT. THE MODIFIED VERSION, NAMELY, DELFIA XPRESS HAFP KIT IS DESIGNED TO BE USED WITH THE 6000 DELFIA XPRESS CLINICAL RANDOM ACCESS SCREENING PLATFORM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DELFIA XPRESS HAFP KIT AND IS INDICATED FOR `THE QUANTITATIVE DETERMINATION OF HUMAN ALPHA-FETOPROTEIN (AFP) IN MATERNAL SERUM AND AMNIOTIC FLUID OBTAINED BETWEEN THE 15TH AND 20TH WEEKS OF GESTATION. THE ASSAY IS TO BE PERFORMED ON THE 6000 DELFIA XPRESS CLINICAL RANDOM ACCESS SCREENING PLATFORM AND IS INTENDED FOR USE ONLY IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY AS AN AID IN THE DETECTION OF OPEN NEURAL TUBE DEFECTS (ONTDS).
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