TOTAL PSA MICROTITER ELISA

Prostate-specific Antigen (psa) For Management Of Prostate Cancers

FDA Premarket Approval P950021 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to add a microtiter plate capture system to the current device. The device, as modified, will be marketed under the trade name oncogene science total psa microtiter elisa and is indicated for the following: the oncogene science total psa microtiter elisa is an in vitro diagnostic assay intended to quantitatively measure total psa in human serum. The assay detects psa both as a free molecule, and when complexed by other molecules, principally alpha-1-antichymotrypsin (act). This device is indicated for the measurement of serum psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. The oncogene science total psa microtiter elisa is further indicated for follow-up and monitoring of patients with prostate cancer. Psa levels measured by this device should be used in conjunction with information available from clinical and other diagnostic procedures in the management of prostate cancer patients.

DeviceTOTAL PSA MICROTITER ELISA
Classification NameProstate-specific Antigen (psa) For Management Of Prostate Cancers
Generic NameProstate-specific Antigen (psa) For Management Of Prostate Cancers
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2001-09-20
Decision Date2002-03-19
PMAP950021
SupplementS004
Product CodeLTJ
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516

Supplemental Filings

Supplement NumberDateSupplement Type
P950021Original Filing
S025 2022-03-22 30-day Notice
S024 2021-04-01 30-day Notice
S023 2020-09-29 30-day Notice
S022 2020-07-31 30-day Notice
S021 2020-03-09 30-day Notice
S020 2020-02-21 30-day Notice
S019
S018 2019-07-03 Special (immediate Track)
S017 2019-02-01 30-day Notice
S016 2018-07-27 Real-time Process
S015 2017-08-01 Normal 180 Day Track
S014 2015-05-07 Normal 180 Day Track
S013 2012-03-26 Normal 180 Day Track No User Fee
S012 2010-08-06 30-day Notice
S011 2009-04-10 Normal 180 Day Track No User Fee
S010 2009-02-06 30-day Notice
S009 2009-03-06 Real-time Process
S008 2006-05-17 Normal 180 Day Track No User Fee
S007 2005-07-22 Real-time Process
S006 2003-07-16 Real-time Process
S005 2001-09-20 Normal 180 Day Track
S004 2001-09-20 Normal 180 Day Track
S003 2000-09-28 Normal 180 Day Track
S002 2000-07-31 Panel Track
S001 1998-12-22 Panel Track

NIH GUDID Devices

Device IDPMASupp
00630414203003 P950021 001
00630414202990 P950021 001
00630414202921 P950021 002
00630414202938 P950021 002
00630414598451 P950021 002
00630414598444 P950021 002
00630414202952 P950021 002
00630414599823 P950021 015
00630414599809 P950021 015
00630414599816 P950021 015
00630414294230 P950021 015

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