IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA

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

FDA Premarket Approval P930027 S013

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

Permanent implementation of the incoming specification for zinc content for 2-amino-2-methyl-1- propanol (amp) buffer and elimination of substrate verification testing.

• Device: IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA
• Classification Name: Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
• Generic Name: Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Date Received: 2011-08-16
• Decision Date: 2011-09-12
• PMA: P930027
• Supplement: S013
• Product Code: MTF
• Advisory Committee: Immunology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS HEALTHCARE DIAGNOSTICS INC. glyn Rhonwy, Llanberis gwynedd Ll55 4el LL554

Supplemental Filings

Supplement Number	Date	Supplement Type
P930027		Original Filing
S028	2022-09-15	30-day Notice
S027
S026	2022-02-28	30-day Notice
S025	2021-04-14	30-day Notice
S024	2020-08-12	30-day Notice
S023	2020-07-23	30-day Notice
S022	2019-11-25	30-day Notice
S021	2019-06-19	Special (immediate Track)
S020	2018-09-28	Real-time Process
S019	2018-03-19	Special (immediate Track)
S018	2017-09-15	Special (immediate Track)
S017	2016-08-17	135 Review Track For 30-day Notice
S016	2014-07-23	135 Review Track For 30-day Notice
S015	2012-05-30	135 Review Track For 30-day Notice
S014	2011-12-19	135 Review Track For 30-day Notice
S013	2011-08-16	30-day Notice
S012	2011-08-08	30-day Notice
S011	2011-02-18	Real-time Process
S010	2009-11-02	Normal 180 Day Track No User Fee
S009
S008	2008-12-16	Normal 180 Day Track
S007	2008-11-10	Normal 180 Day Track No User Fee
S006	2003-11-28	Real-time Process
S005	2003-01-21	Real-time Process
S004	2001-01-02	Panel Track
S003	1998-02-20	Normal 180 Day Track
S002
S001	1995-10-18	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00630414954196	P930027	001
00630414982267	P930027	003
00630414982229	P930027	003
00630414982212	P930027	003
00630414982205	P930027	003
00630414982281	P930027	004