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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.
 
DeviceDIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Applicant
SIEMENS 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[ Registered Establishments with MTG ]
Docket Number 03M-0046
Notice Date 02/05/2003
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 
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