ARCHITECT Total PSA and Alinity i Total PSA

FDA Premarket Approval P910007 S054

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

Adding a process for overhead tank mixing of paramagnetic microparticles using the 650 l microparticle tank in order to improve the manufacturing flexibility of the assays

DeviceARCHITECT Total PSA and Alinity i Total PSA
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantAbbott Laboratories
Date Received2020-10-16
Decision Date2020-11-05
PMAP910007
SupplementS054
Product CodeMTF 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Laboratories 100 Abbott Park Rd. abbott Park, IL 60064-3500

Supplemental Filings

Supplement NumberDateSupplement Type
P910007Original Filing
S054 2020-10-16 30-day Notice
S053 2020-03-16 Normal 180 Day Track No User Fee
S052 2019-01-22 Real-time Process
S051
S050 2017-03-01 30-day Notice
S049 2015-07-16 30-day Notice
S048 2015-02-24 30-day Notice
S047 2014-11-14 30-day Notice
S046 2014-11-13 30-day Notice
S045 2014-06-02 30-day Notice
S044 2014-05-01 30-day Notice
S043 2014-04-16 30-day Notice
S042 2014-01-08 30-day Notice
S041 2013-10-30 30-day Notice
S040 2013-10-28 30-day Notice
S039 2013-02-11 30-day Notice
S038 2012-11-19 30-day Notice
S037 2012-11-15 30-day Notice
S036 2012-11-13 30-day Notice
S035 2012-08-03 30-day Notice
S034 2012-03-06 30-day Notice
S033 2011-11-23 Special (immediate Track)
S032 2011-11-02 135 Review Track For 30-day Notice
S031 2011-09-07 Special (immediate Track)
S030 2011-05-25 30-day Notice
S029 2011-05-04 Normal 180 Day Track No User Fee
S028 2011-04-18 30-day Notice
S027 2011-02-18 30-day Notice
S026 2011-02-17 Normal 180 Day Track No User Fee
S025 2011-01-31 Normal 180 Day Track No User Fee
S024 2010-12-22 Special (immediate Track)
S023 2010-11-22 Normal 180 Day Track No User Fee
S022 2010-11-01 Normal 180 Day Track No User Fee
S021 2010-11-01 Normal 180 Day Track No User Fee
S020 2010-09-27 30-day Notice
S019 2010-07-26 Normal 180 Day Track No User Fee
S018 2010-04-02 Real-time Process
S017 2008-05-21 Normal 180 Day Track
S016 2007-01-17 30-day Notice
S015 2005-08-12 Special (immediate Track)
S014
S013 2005-05-05 Real-time Process
S012 2004-08-30 30-day Notice
S011 2004-07-29 Real-time Process
S010 2004-04-01 Real-time Process
S009 2003-01-31 Normal 180 Day Track
S008 2002-03-18 Special (immediate Track)
S007 2001-12-05 Normal 180 Day Track
S006 2001-06-15 Normal 180 Day Track
S005 1997-09-25 Real-time Process
S004 1994-11-02 Panel Track
S003 1994-08-29 Special (immediate Track)
S002 1994-04-04 Normal 180 Day Track
S001 1992-08-26 Normal 180 Day Track

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