ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Premarket Approval P090008 S001

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 a modification to the device labeling to add a claim defining the immunoassay cutoff-index above which supplemental recombinant immunoblot assay testing is not required.

DeviceELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER
Classification NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantROCHE DIAGNOSTICS CORP.
Date Received2010-07-28
Decision Date2010-09-23
PMAP090008
SupplementS001
Product CodeMZO
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250

Supplemental Filings

Supplement NumberDateSupplement Type
P090008Original Filing
S023 2022-09-30 Real-time Process
S022
S021 2018-10-26 Normal 180 Day Track No User Fee
S020 2018-04-17 Real-time Process
S019 2017-10-11 Real-time Process
S018 2017-08-03 30-day Notice
S017 2016-02-16 30-day Notice
S016 2016-01-27 30-day Notice
S015 2015-10-07 30-day Notice
S014 2014-08-22 30-day Notice
S013 2014-04-04 Real-time Process
S012 2012-11-30 30-day Notice
S011 2012-09-05 30-day Notice
S010
S009 2012-02-29 30-day Notice
S008 2012-01-31 135 Review Track For 30-day Notice
S007 2011-11-21 30-day Notice
S006 2011-11-01 Normal 180 Day Track
S005 2011-08-29 135 Review Track For 30-day Notice
S004 2011-08-17 135 Review Track For 30-day Notice
S003 2011-05-17 Normal 180 Day Track No User Fee
S002 2011-04-11 30-day Notice
S001 2010-07-28 Normal 180 Day Track

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