BAYER ADVIA IMS PSA ASSAY

Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Premarket Approval P950021 S006

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 of the immuno 1 prostate specific antigen (psa) on the advia integrated modular system (ims). The device, as modified, will be marketed under the trade name advia ims prostate specific antigen (psa) and is indicated for: the advia ims prostate specific antigen (psa) method is for in vitro diagnostic use to quantitatively measure prostate specific antigen (psa) in human serum. This assay is indicated for the measurement of the serum psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 year and older. This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients. This diagnostic method is not intended for use on any other system.

DeviceBAYER ADVIA IMS PSA ASSAY
Classification NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2003-07-16
Decision Date2003-09-02
PMAP950021
SupplementS006
Product CodeMTF
Advisory CommitteeImmunology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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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