ADVIA CENTAUR AHBS

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

FDA Premarket Approval P030029 S003

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

Approval for the transition of the advia centaur anti-hbs assay to a new platform in the centaur family of instruments, the centaur cp. Advia centaur anti-hbs readypack reagents on the centaur cp analyzerthe advia centaur anti-hbs assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis b surface antigen in humanserum or plasma (edta or heparinized) using the advia centaur cp system. 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 serologicalmarkers for the laboratory diagnosis of hbv disease associated with hbv infection. Areactive assay result will allow a differential diagnosis in individuals displaying signs andsymptoms of hepatitis in whom etiology is unknown. Advia centaur anti-hbs quality controls on the centaur cp analyzerthe advia centaur anti-hbs quality controls are intended for in vitro diagnostic use in monitoring the performance of the anti-hbs assay on the advia centaur systems. The performance of the advia centaur anti-hbs quality controls has not been established with any other anti-hbs assay.

• Device: ADVIA CENTAUR AHBS
• 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: 2008-08-11
• Decision Date: 2009-07-31
• PMA: P030029
• Supplement: S003
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032

Supplemental Filings

Supplement Number	Date	Supplement Type
P030029		Original Filing
S013	2012-03-26	Normal 180 Day Track No User Fee
S012	2011-02-16	30-day Notice
S011	2010-09-29	30-day Notice
S010
S009	2009-09-28	Normal 180 Day Track
S008	2009-08-21	30-day Notice
S007	2009-05-18	Normal 180 Day Track
S006	2009-03-31	Normal 180 Day Track
S005	2009-03-03	Normal 180 Day Track No User Fee
S004	2008-09-18	Normal 180 Day Track
S003	2008-08-11	Normal 180 Day Track
S002
S001	2007-03-14	135 Review Track For 30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00630414471860	P030029	000
00630414471914	P030029	003