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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(R) RXL PSA FLEX(R) REAGENT CARTRIDGE
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
PO BOX 6101
NEWARK, DE 19714-6101
PMA NumberP000021
Date Received06/05/2000
Decision Date07/05/2001
Product Codes LTJ MTF 
Docket Number 01M-0310
Notice Date 07/23/2001
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE. THE DEVICE IS INDICATED FOR THE FOLLOWING: THE PSA METHOD FOR THE DIMENSION(R) CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN AGED 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER. 2) AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S037 
S038 S039 S040 S041 S042 S043 S044 S045 
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