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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.
 
Trade NameTANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Nametandem free psa assays
ApplicantBECKMAN COULTER, INC.
PMA NumberP970038
Date Received08/29/1997
Decision Date03/10/1998
Product Code
MTG[ Registered Establishments with MTG ]
Docket Number 98M-0201
Notice Date 04/16/1998
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
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 
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