BAYER IMMUNO 1 SYSTEM

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

FDA Premarket Approval P950021 S001

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 for the bayer immuno 1(tm) psa assay. 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. This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.

• Device: BAYER IMMUNO 1 SYSTEM
• Classification Name: Prostate-specific Antigen (psa) For Management Of Prostate Cancers
• Generic Name: Prostate-specific Antigen (psa) For Management Of Prostate Cancers
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS
• Date Received: 1998-12-22
• Decision Date: 1999-06-25
• PMA: P950021
• Supplement: S001
• Product Code: LTJ
• Docket Number: 99M-2748
• Advisory Committee: Immunology
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P950021		Original 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 ID	PMA	Supp
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