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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.
 
DeviceTANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantBECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD M/S
W-110
BREA, CA 92822
PMA NumberP970038
Date Received08/29/1997
Decision Date03/10/1998
Product Code MTG 
Docket Number 98M-0201
Notice Date 04/16/1998
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Tandem(R)-R free PSA assay and Tandem(R)-MP free PSA assay. The Tandem(R)-R free PSA Immunoradiometric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum. The Tandem(R)-MP free PSA Immunoenzymetric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum. Hybritech's Tandem free PSA assays are intened to beused with Tandem (total) PSa to calculate the ration of fee PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by Hybritech's Tandem assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic condtions, when used in conjuction with Tandem (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/ml and digital rectal examination finding that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S036 S037 S039 
S040 S041 S042 S043 S044 S045 
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