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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceIMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
GLYN RHONWY. LLANBERIS
CAERNARFON
GWYNEDD, LL55 4EL
PMA NumberP060005
Date Received02/14/2006
Decision Date05/11/2007
Product Code MTG 
Docket Number 07M-0409
Notice Date 11/09/2007
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAY. THESE DEVICES ARE INDICATED FOR: THE IMMULITE / IMMULITE 1000 FREE PSA ASSAY IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE / IMMULITE 1000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE-SPECIFIC ANTIGEN (PSA) NOT BOUND TO ALPHA 1-ANTICHYMOTRYPSIN OR OTHER BINDING PROTEINS (UNCOMPLEXED) IN HUMAN SERUM (INCLUDING SERUM COLLECTED IN SERUM GLASS, SERUM PLASTIC AN SERUM GEL SEPARATOR TUBES). MEASUREMENT OF FREE PSA IS USED IN CONJUNCTION WITH IMMULITE / IMMULITE 1000 TOTAL PSA TO DETERMINE A RATIO OF FREE PSA TO TOTAL PSA (PERCENT FREE PSA). THE PERCENT FREE PSA IS USED AS AN AID IN DISCRIMINATING PROSTATE CANCER FROM BENIGN DISEASE IN MEN 50 YEARS OR OLDER WITH IMMULITE / IMMULITE 1000 TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND DIGITAL RECTAL EXAM (DRE) FINDINGS NOT SUSPICIOUS OF CANCER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE IMMULITE 2000 FREE PSA ASSAY IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE-SPECIFIC ANTIGEN (PSA) NOT BOUND TO ALPHA 1-ANTICHYMOTRYPSIN OR OTHER BINDING PROTEINS (UNCOMPLEXED) IN HUMAN SERUM (INCLUDING SERUM COLLECTED IN SERUM GLASS, SERUM PLASTIC AN SERUM GEL SEPARATOR TUBES). MEASUREMENT OF FREE PSA IS USED IN CONJUNCTION WITH IMMULITE 2000 TOTAL PSA TO DETERMINE A RATIO OF FREE PSA TO TOTAL PSA (PERCENT FREE PSA). THE PERCENT FREE PSA IS USED AS AN AID IN DISCRIMINATING PROSTATE CANCER FROM BENIGN DISEASE IN MEN 50 YEARS OR OLDER WITH IMMULITE 2000 TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND DIGITAL RECTAL EXAM (DRE) FINDINGS NOT SUSPICIOUS OF CANCER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 
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