Elecsys total PSA Test System

FDA Premarket Approval P990056 S038

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

Expansion of manufacturing activities for the production of lyophilized calibrators to an additional building within the same manufacturing site.

DeviceElecsys total PSA Test System
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantROCHE DIAGNOSTICS CORP.
Date Received2021-10-18
Decision Date2021-11-16
PMAP990056
SupplementS038
Product CodeMTF 
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250

Supplemental Filings

Supplement NumberDateSupplement Type
P990056Original Filing
S038 2021-10-18 30-day Notice
S037 2019-11-14 Normal 180 Day Track
S036 2019-01-29 Real-time Process
S035 2018-10-26 Normal 180 Day Track No User Fee
S034 2018-10-01 30-day Notice
S033 2018-04-17 Real-time Process
S032 2018-04-03 30-day Notice
S031 2018-03-01 Real-time Process
S030
S029 2017-10-11 Real-time Process
S028 2017-07-31 Normal 180 Day Track
S027 2017-08-03 30-day Notice
S026 2017-05-24 30-day Notice
S025 2016-10-26 30-day Notice
S024 2016-09-07 Normal 180 Day Track No User Fee
S023 2016-02-18 30-day Notice
S022 2015-10-07 30-day Notice
S021 2014-04-04 Real-time Process
S020 2013-04-09 Real-time Process
S019 2012-11-30 30-day Notice
S018
S017 2012-02-29 30-day Notice
S016 2012-01-31 135 Review Track For 30-day Notice
S015 2011-11-22 30-day Notice
S014 2011-08-01 Normal 180 Day Track
S013 2011-05-03 Normal 180 Day Track No User Fee
S012 2011-04-25 30-day Notice
S011 2011-04-11 135 Review Track For 30-day Notice
S010 2009-10-07 135 Review Track For 30-day Notice
S009 2008-09-02 30-day Notice
S008 2008-03-28 Normal 180 Day Track
S007 2007-08-22 Normal 180 Day Track
S006 2006-12-28 30-day Notice
S005
S004 2006-10-05 Real-time Process
S003 2006-02-13 Normal 180 Day Track
S002 2006-01-23 Special (immediate Track)
S001 2001-10-09 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04015630921515 P990056 000
04015630920754 P990056 000
04015630920877 P990056 001
07613336154380 P990056 024
04015630920877 P990056 024
04015630921515 P990056 024
04015630939824 P990056 028
07613336166000 P990056 037
07613336165997 P990056 037
07613336165980 P990056 037
07613336167496 P990056 037

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