Atellica IM Prostate-Specific Antigen (PSA) Assay

FDA Premarket Approval P950021 S024

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

For moving manufacturing of atellica im analyzer’s component/subassembly named autoloader to an internal supplier

DeviceAtellica IM Prostate-Specific Antigen (PSA) Assay
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Date Received2021-04-01
Decision Date2021-04-27
Product CodeMTG 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516

Supplemental Filings

Supplement NumberDateSupplement Type
P950021Original Filing
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
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


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

© 2021
This site is not affiliated with or endorsed by the FDA.