ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL

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

FDA Premarket Approval P090024

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for advia centaur hbeag assay & advia centaur hbeag quality control material. This device is indicated for:advia centaur hbeag assay:the advia centaur hbeag assay is an in-vitro diagnostic immunoassay for the qualitative determination of the hepatitis b e antigen (hbeag) in human serum and plasma (potassium edta, lithium or sodium heparin) from individuals who have signs andsymptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection using the advia centaur and advia centaur xp systems. This assay, in conjunction with other serological and clinical information, is intended only for the determination of chronic infection with hepatitis b virus. Advia centaur hbeag quality control material:the controls are used for monitoring the performance of the hbeag assay on the advia centaur systems. The performance of the hbeag quality control material has not been established with any other hbeag assay.

Device	ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
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	2009-10-22
Decision Date	2011-10-11
Notice Date	2011-10-20
PMA	P090024
Supplement	S
Product Code	LOM
Docket Number	11M-0737
Advisory Committee	Microbiology
Expedited Review	No
Combination Product	No
Applicant Address	SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue tarrytown, NY 10591
Summary:	Summary of Safety and Effectiveness
Labeling:	Labeling
Approval Order:	Approval Order

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