ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL

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

FDA Premarket Approval P100039

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 anti-hbs2 (ahbs2) assay and advia centaur anti-hbs2 (ahbs2) quality control material for use on the advia centaur and advia centaur xp systems. This device is indicated for: advia centaur anti-hbs2 (ahbs2) assay, the advia centaur anti-hb2 assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis b surface antigen in human adult, adolescent, and pediatric serum of plasma (edta, lithium-heparinized, or sodium-heparinized) and neonatal samples using the advia centaur and advia centaur xp systems. The assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection in individuals prior to or following hbv vaccination or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. This assay has not been fda-cleared or approved for the screening of blood or plasma donors. Advia centaur anti-hbs2 (ahbs2) quality control material, for in vitro diagnostic use in monitoring the performance of the anti-hbs2 assay on the advia centaur systems. The performance of the anti-hbs2 quality control material has not been established with any other anti-hbs assays.

DeviceADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
Classification NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
Date Received2010-08-17
Decision Date2012-01-20
Notice Date2012-01-24
PMAP100039
SupplementS
Product CodeLOM
Docket Number12M-0075
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 Benedict Ave. tarrytown, NY 10591
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P100039Original Filing
S015 2022-03-22 30-day Notice
S014 2022-01-20 30-day Notice
S013 2021-04-01 30-day Notice
S012 2021-03-26 30-day Notice
S011 2020-12-22 Real-time Process
S010 2020-07-31 30-day Notice
S009 2020-03-09 30-day Notice
S008 2020-02-21 30-day Notice
S007 2019-02-01 30-day Notice
S006 2018-07-19 Real-time Process
S005 2017-07-14 Normal 180 Day Track
S004 2015-07-13 Normal 180 Day Track
S003 2015-06-11 30-day Notice
S002 2012-09-28 Real-time Process
S001 2012-04-30 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00630414597843 P100039 001
00630414597836 P100039 001
00630414591407 P100039 001
00630414561790 P100039 001
00630414551777 P100039 001
00630414301273 P100039 001
00630414600512 P100039 002
00630414555300 P100039 002

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