Elecsys total PSA

FDA Premarket Approval P990056 S037

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 the update of the elecsys total psa immunoassay to improve the tolerance to biotin interference.

DeviceElecsys total PSA
Generic NameTotal, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
ApplicantROCHE DIAGNOSTICS CORP.
Date Received2019-11-14
Decision Date2020-05-12
PMAP990056
SupplementS037
Product CodeMTF 
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250

Supplemental Filings

Supplement NumberDateSupplement Type
P990056Original Filing
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
04015630939824 P990056 028

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