Elecsys Anti-HBc Immunoassay test system

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

FDA Premarket Approval P100031 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 1) the inclusion of a second antigen source for the recombinant hepatitis b core antigen used in reagent 1 of the test kit;, 2) an update in the device by changing the standardization traceability to the world health organization standard nibsc 95/522; 3) extension of the reagent rackpack onboard stability from 4 weeks to 8 weeks, 4) addition of k3-edta plasma as a specimen type, and 5) modification of the device name.

• Device: Elecsys Anti-HBc Immunoassay test system
• Classification Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Generic Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Applicant: ROCHE DIAGNOSTICS CORP.
• Date Received: 2017-02-21
• Decision Date: 2017-08-16
• PMA: P100031
• Supplement: S017
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250

Supplemental Filings

Supplement Number	Date	Supplement Type
P100031		Original Filing
S027	2021-09-30	Normal 180 Day Track
S026	2018-10-26	Normal 180 Day Track No User Fee
S025	2018-10-09	30-day Notice
S024	2018-04-17	Real-time Process
S023	2018-03-01	Real-time Process
S022
S021	2017-10-11	Real-time Process
S020	2017-09-28	Normal 180 Day Track
S019	2017-08-03	30-day Notice
S018	2017-05-24	30-day Notice
S017	2017-02-21	Normal 180 Day Track
S016	2016-02-16	30-day Notice
S015	2016-01-27	30-day Notice
S014	2016-01-27	135 Review Track For 30-day Notice
S013	2015-10-07	30-day Notice
S012	2014-10-16	Real-time Process
S011	2014-04-04	Real-time Process
S010	2012-11-30	30-day Notice
S009	2012-09-04	Normal 180 Day Track
S008	2012-09-04	Normal 180 Day Track
S007
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

NIH GUDID Devices

Device ID	PMA	Supp
07613336153925	P100031	000
07613336153949	P100031	017