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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDIMENSION TPSA FLEX REAGENT CARTRIDGE
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
ApplicantDADE BEHRING, INC.
PMA NumberP000021
Supplement NumberS002
Date Received03/26/2002
Decision Date09/10/2002
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes. The design changes include modification of the assay response to provide equivalent results for samples with varying mixtures of free psa and psa-act and optimization of the method design to minimize method response to human anti-murine immunoglobulin antibodies and human anti-bovine immunoglobulin antibodies. The device, as modified, will be marketed under the trade name dimension tpsa flex reagent cartridge and is indicated for: the tpsa method for the dimension clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure total prostate specific antigen (psa) in human serum and plasma: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer 2) as an aid in the management (monitoring) of prostate cancer patients.
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