Elecsys Anti-HBc IgM Immunoassay

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

FDA Premarket Approval P110022 S021

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

Change to the manufacture of microparticles.

DeviceElecsys Anti-HBc IgM Immunoassay
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 Received2017-05-24
Decision Date2017-06-23
PMAP110022
SupplementS021
Product CodeLOM
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 Road p.o. Box 50416 indianapolis, IN 46250-0457

Supplemental Filings

Supplement NumberDateSupplement Type
P110022Original Filing
S028 2021-12-02 30-day Notice
S027 2018-10-26 Normal 180 Day Track No User Fee
S026 2018-10-09 30-day Notice
S025 2018-04-17 Real-time Process
S024 2017-10-11 Real-time Process
S023 2017-08-03 30-day Notice
S022 2017-07-06 Normal 180 Day Track
S021 2017-05-24 30-day Notice
S020 2016-12-07 Real-time Process
S019 2016-09-07 Normal 180 Day Track No User Fee
S018 2016-07-11 135 Review Track For 30-day Notice
S017 2016-02-16 30-day Notice
S016 2016-01-27 30-day Notice
S015 2016-01-27 135 Review Track For 30-day Notice
S014 2015-10-07 30-day Notice
S013 2014-10-16 Real-time Process
S012 2014-04-04 Real-time Process
S011 2013-07-19 Special (immediate Track)
S010
S009 2012-11-30 30-day Notice
S008 2012-08-31 Normal 180 Day Track
S007
S006 2012-02-29 30-day Notice
S005 2012-02-02 30-day Notice
S004 2012-02-02 30-day Notice
S003 2012-02-02 30-day Notice
S002 2012-01-31 135 Review Track For 30-day Notice
S001 2012-01-31 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
07613336153932 P110022 022

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