ADVIA Centaur HBsAg

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

FDA Premarket Approval P030049 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

Implement two additional tiers of standards identical to the approved standard used in manufacturing.

• Device: ADVIA Centaur HBsAg
• 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: SIEMENS HEALTHCARE DIAGNOSTICS
• Date Received: 2019-09-27
• Decision Date: 2019-10-25
• PMA: P030049
• 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: SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516

Supplemental Filings

Supplement Number	Date	Supplement Type
P030049		Original Filing
S016	2020-12-22	Real-time Process
S015	2020-07-31	30-day Notice
S014	2020-02-21	30-day Notice
S013	2019-09-27	30-day Notice
S012	2015-06-11	30-day Notice
S011	2014-07-10	Real-time Process
S010	2012-03-26	Normal 180 Day Track No User Fee
S009
S008	2010-04-06	30-day Notice
S007	2009-05-18	Normal 180 Day Track
S006	2009-05-12	30-day Notice
S005	2009-03-31	Normal 180 Day Track
S004	2009-03-09	Normal 180 Day Track No User Fee
S003	2009-02-04	30-day Notice
S002	2008-07-30	Normal 180 Day Track
S001

NIH GUDID Devices

Device ID	PMA	Supp
00630414472881	P030049	000
00630414472874	P030049	002
00630414472867	P030049	002