ABBOTT IMX FREE PSA

FDA Premarket Approval P980007 S003

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 modification of the abbott architect free psa reagents to be used with the imx free psa and is indicated for: the imx free psa assay is a microparticle enzyme immunoassay (meia) for the quantitative measurement of free prostate specific antigen (psa) in human serum. The imx free psa assay is intended to be used in conjunction with the imx total psa assay in men aged 50 years or older with total psa values between 4 and 10 ng/ml and non-suspicious dre to determine the % free psa value. The imx % free psa value can be used as an aid in discriminating between prostate cancer and benign disease.

DeviceABBOTT IMX FREE PSA
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantAbbott Laboratories
Date Received2003-01-31
Decision Date2004-02-05
PMAP980007
SupplementS003
Product CodeMTG 
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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
S048 2023-01-06 30-day Notice
S047 2022-09-14 30-day Notice
S046 2021-11-18 30-day Notice
S045 2021-11-09 30-day Notice
S044 2021-02-09 Real-time Process
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.