Elecsys free PSA Test System, Biotin remediation

FDA Premarket Approval P000027 S035

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 free psa immunoassay to improve the tolerance to biotin interference.

DeviceElecsys free PSA Test System, Biotin remediation
Generic NameTest, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
ApplicantROCHE DIAGNOSTICS CORP.
Date Received2019-11-27
Decision Date2020-05-12
PMAP000027
SupplementS035
Product CodeMTG 
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
P000027Original Filing
S035 2019-11-27 Normal 180 Day Track
S034 2019-01-29 Real-time Process
S033 2018-10-26 Normal 180 Day Track No User Fee
S032 2018-10-01 30-day Notice
S031 2018-04-17 Real-time Process
S030 2018-03-01 Real-time Process
S029
S028 2017-10-11 Real-time Process
S027 2017-08-28 Normal 180 Day Track
S026 2017-08-03 30-day Notice
S025 2017-05-24 30-day Notice
S024 2016-10-26 30-day Notice
S023 2016-09-07 Normal 180 Day Track No User Fee
S022 2016-02-18 30-day Notice
S021 2015-10-07 30-day Notice
S020 2014-11-25 30-day Notice
S019 2014-04-04 Real-time Process
S018 2013-04-09 Real-time Process
S017 2012-12-19 135 Review Track For 30-day Notice
S016
S015 2012-02-29 30-day Notice
S014 2012-01-31 135 Review Track For 30-day Notice
S013 2011-11-22 30-day Notice
S012 2011-08-01 Normal 180 Day Track
S011 2011-05-03 Normal 180 Day Track No User Fee
S010 2011-04-25 30-day Notice
S009 2011-04-11 135 Review Track For 30-day Notice
S008 2010-05-27 30-day Notice
S007 2008-09-02 30-day Notice
S006 2008-03-28 Normal 180 Day Track
S005 2007-07-23 Normal 180 Day Track
S004 2006-12-22 30-day Notice
S003
S002 2002-10-11 Normal 180 Day Track
S001 2001-11-07 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04015630919338 P000027 000
04015630919321 P000027 000
04015630997053 P000027 000
04015630940011 P000027 027

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