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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.
 
DeviceACS 180/ADVIA CENTAUR AFP IMMUNOASSAY
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSiemens Healthcare Diagnostics, Inc.
333 Coney St.
East Walpole, MA 02032
PMA NumberP930036
Supplement NumberS003
Date Received07/22/2005
Decision Date10/07/2005
Product Code LOK 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ACS:180 AND THE CENTAUR AFP ASSAYS ON THE ADVIA CENTAUR CP SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR CP AFP AND IS INDICATED FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN 1) HUMAN SERUM AND IN AMNIOTIC FLUID FROM SPECIMENS OBTAINED AT 15 AND 20 WEEKS GESTATION, AS AN AID IN DETECTING OPEN NEURAL TUBE DEFECTS (NTDS) WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY AND AMNIOGRAPHY TESTING 2) HUMAN SERUM, AS AN AID IN MANAGING NON-SEMINOMATOUS TESTICULAR CANCER WHEN USED IN CONJUNCTION WITH PHYSICAL EXAMINATION, HISTOLOGY/PATHOLOGY, AND OTHER CLINICAL EVALUATION PROCEDURES, USING THE (BAYER) SYSTEM.
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