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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.
 
DeviceDIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE, P O BOX 6101
M/S 514
NEWARK, DE 19714-6101
PMA NumberP020027
Date Received07/05/2002
Decision Date01/24/2003
Product Code MTG 
Docket Number 03M-0046
Notice Date 02/05/2003
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS. THE DIMENSION FPSA FLEX REAGENT CARTRIDGE IS INDICATED FOR: THE FPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE FREE PROSTATE SPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM. MEASUREMENT OF FPSA ARE USED IN CONJUNCTION WITH TOTAL PSA (TPSA) METHOD ON DIMENSION SYSTEM 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 10.0 NG/ML [UG/L] AND DIGITAL RECTAL EXAMINATION (DRE) FINDINGS NOT SUSPICIOUS FOR CANCER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. THE DIMENSION T/F PSA CALIBRATOR IS INDICATED FOR: THE T/F PSA CALIBRATOR IS AN IN VITRO DIAGNOSTIC PRODUCT INTENDED TO BE USED TO CALIBRATE THE TOTAL (TPSA) AND FREE (FPSA) PROSTATE SPECIFIC ANTIGEN METHODS FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE. THIS PRODUCT WAS DESIGNED TO MEET THE NEEDS OF USERS TO ASSURE ACCURATE RESULTS OVER THE ASSAY RANGE OF THESE METHODS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S032 S033 S034 S035 S036 
S037 S038 S039 S040 
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