ARCHITECT Free PSA and Alinity i Free PSA

FDA Premarket Approval P980007 S043

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 Free PSA and Alinity i Free PSA
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantAbbott Laboratories
Date Received2020-10-16
Decision Date2020-11-05
PMAP980007
SupplementS043
Product CodeMTG 
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. ap5n-2 Dept 09vb abbott Park, IL 60064-6070

Supplemental Filings

Supplement NumberDateSupplement Type
P980007Original Filing
S043 2020-10-16 30-day Notice
S042 2020-03-16 Normal 180 Day Track No User Fee
S041
S040 2015-07-16 30-day Notice
S039 2015-02-24 30-day Notice
S038 2014-11-14 30-day Notice
S037 2014-11-13 30-day Notice
S036 2014-06-02 30-day Notice
S035 2014-04-18 30-day Notice
S034 2014-04-16 30-day Notice
S033 2014-01-08 30-day Notice
S032 2013-10-30 30-day Notice
S031 2013-10-28 30-day Notice
S030 2013-02-11 30-day Notice
S029 2012-11-19 30-day Notice
S028 2012-11-15 30-day Notice
S027 2012-11-13 30-day Notice
S026 2012-07-03 30-day Notice
S025 2012-03-06 30-day Notice
S024 2011-11-23 Special (immediate Track)
S023 2011-11-02 135 Review Track For 30-day Notice
S022 2011-09-07 Special (immediate Track)
S021 2011-05-25 30-day Notice
S020 2011-05-04 Normal 180 Day Track No User Fee
S019 2011-04-18 30-day Notice
S018 2011-02-18 30-day Notice
S017 2011-02-17 Normal 180 Day Track No User Fee
S016 2011-01-31 Normal 180 Day Track No User Fee
S015 2010-12-22 Special (immediate Track)
S014
S013 2010-11-01 Normal 180 Day Track No User Fee
S012 2010-09-27 30-day Notice
S011 2010-08-09 Normal 180 Day Track No User Fee
S010 2010-04-02 Real-time Process
S009 2008-05-21 Normal 180 Day Track
S008 2007-01-17 30-day Notice
S007
S006 2004-08-30 30-day Notice
S005 2004-08-05 Real-time Process
S004 2004-04-01 Real-time Process
S003 2003-01-31 Normal 180 Day Track
S002 2002-02-01 Normal 180 Day Track
S001 2001-06-15 Normal 180 Day Track

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