Elecsys Anti-HBc II

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Approval P100032 S017

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 implementation of system software 06-04 on the cobas e 602 to address a software limitation

DeviceElecsys Anti-HBc II
Classification NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantROCHE DIAGNOSTICS CORP.
Date Received2017-10-11
Decision Date2017-12-20
PMAP100032
SupplementS017
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
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
P100032Original Filing
S021 2021-09-30 Normal 180 Day Track
S020 2018-10-26 Normal 180 Day Track No User Fee
S019 2018-10-09 30-day Notice
S018 2018-03-01 Real-time Process
S017 2017-10-11 Real-time Process
S016 2017-08-03 30-day Notice
S015 2017-05-24 30-day Notice
S014 2017-02-21 Normal 180 Day Track
S013 2016-02-16 30-day Notice
S012 2016-01-27 30-day Notice
S011 2016-01-27 135 Review Track For 30-day Notice
S010 2015-10-07 30-day Notice
S009 2013-04-09 Real-time Process
S008 2012-11-30 30-day Notice
S007 2012-09-04 Normal 180 Day Track
S006 2012-02-29 30-day Notice
S005 2012-01-31 135 Review Track For 30-day Notice
S004 2011-08-29 135 Review Track For 30-day Notice
S003 2011-08-17 Normal 180 Day Track No User Fee
S002 2011-08-17 135 Review Track For 30-day Notice
S001 2011-07-01 30-day Notice

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