Elecsys HBsAg II

FDA Premarket Approval P160019 S013

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

To improve and expand manufacturing of kit components

• Device: Elecsys HBsAg II
• Generic Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Applicant: ROCHE DIAGNOSTICS, INC.
• Date Received: 2021-11-29
• Decision Date: 2021-12-16
• PMA: P160019
• Supplement: S013
• 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, INC. 9115 Hague Road indianapolis, IN 46038

Supplemental Filings

Supplement Number	Date	Supplement Type
P160019		Original Filing
S013	2021-11-29	30-day Notice
S012	2021-08-02	Normal 180 Day Track
S011	2019-11-27	Normal 180 Day Track
S010	2019-09-03	Normal 180 Day Track
S009	2018-10-26	Normal 180 Day Track No User Fee
S008	2018-10-09	30-day Notice
S007	2018-04-17	Real-time Process
S006	2017-10-11	Real-time Process
S005	2017-08-03	30-day Notice
S004	2017-07-28	Normal 180 Day Track
S003	2017-07-28	Normal 180 Day Track
S002	2017-05-24	30-day Notice
S001	2017-05-09	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
07613336106402	P160019	000
04015630939008	P160019	000
04015630911110	P160019	000
07613336106396	P160019	000
04015630940028	P160019	004
07613336198285	P160019	010
07613336198278	P160019	010
07613336168103	P160019	010
07613336172902	P160019	011
07613336164372	P160019	011
07613336175293	P160019	012