TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY

Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Premarket Approval P970038

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.

Pre-market Approval Supplement Details

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.

DeviceTANDEM-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 NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantBECKMAN COULTER, INC.
Date Received1997-08-29
Decision Date1998-03-10
Notice Date1998-04-16
PMAP970038
SupplementS
Product CodeMTG
Docket Number98M-0201
Advisory CommitteeImmunology
Expedited ReviewNo
Combination Product No
Applicant Address BECKMAN COULTER, INC. 250 South Kraemer Blvd M/s w-110 brea, CA 92822

Supplemental Filings

Supplement NumberDateSupplement Type
P970038Original Filing
S045 2021-04-19 Real-time Process
S044 2020-09-30 Real-time Process
S043 2020-07-22 Real-time Process
S042 2020-06-23 Real-time Process
S041 2019-12-18 Real-time Process
S040 2019-05-13 Real-time Process
S039 2019-05-02 Real-time Process
S038
S037 2018-09-25 Real-time Process
S036 2017-09-28 30-day Notice
S035
S034 2017-06-09 30-day Notice
S033 2017-03-22 Real-time Process
S032 2017-01-17 30-day Notice
S031 2015-05-07 Real-time Process
S030 2015-01-27 135 Review Track For 30-day Notice
S029 2014-11-04 135 Review Track For 30-day Notice
S028 2014-08-25 Real-time Process
S027 2014-08-25 135 Review Track For 30-day Notice
S026 2013-12-17 Real-time Process
S025 2013-09-26 Special (immediate Track)
S024 2013-06-13 Special (immediate Track)
S023 2013-04-12 Special (immediate Track)
S022 2013-03-29 Real-time Process
S021 2013-01-23 Real-time Process
S020 2013-01-03 30-day Notice
S019
S018
S017 2012-10-25 Special (immediate Track)
S016 2012-03-15 Special (immediate Track)
S015 2011-12-23 Real-time Process
S014 2011-01-12 Special (immediate Track)
S013 2011-01-10 Special (immediate Track)
S012 2008-05-27 Normal 180 Day Track
S011 2007-12-19 Real-time Process
S010 2007-05-14 30-day Notice
S009 2007-05-16 Normal 180 Day Track
S008 2006-04-10 Real-time Process
S007 2002-12-20 Real-time Process
S006 2002-10-07 Real-time Process
S005 2002-08-19 Normal 180 Day Track
S004 1999-08-27 Normal 180 Day Track
S003 1999-05-14 Normal 180 Day Track
S002 1999-04-27 Normal 180 Day Track
S001 1998-07-23 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
H628372101 P970038 004

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