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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
500 gbc drive
po box 6101
newark, DE 19714-6101
PMA NumberP000021
Date Received06/05/2000
Decision Date07/05/2001
Product Code
LTJ[ Registered Establishments with LTJ ]
Docket Number 01M-0310
Notice Date 07/23/2001
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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