Atellica IM Hepatitis B e Antigen (HBeAg) Assay

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

FDA Premarket Approval P090024 S006

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

Adding an additional manufacturing site for the instrument module

• Device: Atellica IM Hepatitis B e Antigen (HBeAg) Assay
• 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: 2019-02-01
• Decision Date: 2019-03-08
• PMA: P090024
• Supplement: S006
• 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 511 Benedict Avenue tarrytown, NY 10591

Supplemental Filings

Supplement Number	Date	Supplement Type
P090024		Original Filing
S011	2022-03-22	30-day Notice
S010	2021-04-01	30-day Notice
S009	2020-07-31	30-day Notice
S008	2020-03-09	30-day Notice
S007	2020-02-21	30-day Notice
S006	2019-02-01	30-day Notice
S005	2018-07-19	Real-time Process
S004	2017-12-22	Normal 180 Day Track
S003	2017-03-27	30-day Notice
S002	2015-06-11	30-day Notice
S001	2015-05-05	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00630414591315	P090024	000
00630414531298	P090024	000
00630414599236	P090024	001
00630414599229	P090024	001
00630414301310	P090024	001