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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.
 
DeviceFPSA FLEX REAGENT CARTRIDGE
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSiemens Healthcare Diagnostics
500 Gbc Dr. P.O. Box 6101. M/S 514
Newark, DE 19714
PMA NumberP020027
Supplement NumberS009
Date Received12/02/2008
Decision Date05/17/2010
Product Code MTG 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES:1) DETECTION TECHNOLOGY FROM SPECTROPHOTOMETRY TO CHEMILUMINESENCE;2) APPROPRIATE REAGENT PROCESS CHANGES TO ACCOMMODATE CHEMILUMINESENCE DETECTION;3) USAGE ON THE DIMENSION VISTA 1500 SYSTEM;4) USAGE ON THE DIMENSION VISTA 3000T SYSTEM WHICH CONSISTS OF TWO DIMENSION VISTA1500 SYSTEMS CONNECTED BY A SAMPLE TRACK TRANSPORT MECHANISM; AND5) USAGE ON THE DIMENSION VISTA 1500 SYSTEM CONNECTED TO THE STREAMLAB ANALYTICALWORKCELL LABORATORY AUTOMATION SYSTEM.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIMENSION VISTA FPSA FLEXREAGENT CARTRIDGE AND IS INDICATED FOR:THE FPSA METHOD FOR THE DIMENSION VISTA SYSTEM IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE FREE PROSTATESPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM AND PLASMA. MEASUREMENTS OF FPSA ARE USED IN CONJUNCTION WITH TOTAL PSA (TPSA) METHOD ON DIMENSION VISTA SYSTEN TO CALCULATE FPSA TO TPSA RATIO EXPRESSED AS A PERCENT FPSA. THE PERCENT FPSA IS USED AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATE CONDITIONS IN MEN 50 YEARS OR OLDER WITH TPSA OF 4.0 TO 1.0 NG/ML AND DRE FINDINGS NOT SUSPICIOUS FOR CANCER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.
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