ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC

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

FDA Premarket Approval P100031 S016

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

Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.

• Device: ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC
• 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: 2016-02-16
• Decision Date: 2016-03-16
• PMA: P100031
• Supplement: S016
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• 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