ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

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

FDA Premarket Approval P030040 S011

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 a claim to test a pediatric population with the fda approved advia centaur® hbc igm readypack reagents and advia centaur® hbc igm quality control materials. The device, as modified, will be marketed under the trade name advia centaur® hbc igm assay and is indicated for:advia centaur, advia centaur xp, and advia centaur xpt systemsthe advia centaur® hbc igm (ahbcm) assay is an in vitro diagnostic test for the qualitative determination of lgm response to hepatitis b virus core antigen in human pediatric (2 through 21 years) and adult serum and plasma (edta or lithium or sodium heparinized) using the advia centaur, advia centaur xp, and advia centaur xpt systems. The assay uses recombinant hbc antigen. This assay may be used in combination with other hepatitis b virus (hbv) marker assays to define the clinical status of known hbv infected patients or can be combined with other hbv, hav (hepatitis a virus), and hcv (hepatitis c virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age. Assay performance characteristics have not been established when the advia centaur hbc igm assay is used in conjunction with other manufacturers' assays for specific hbv serological markers. Advia centaur cp systemthe advia centaur® hbc igm assay is an in vitro diagnostic test for the qualitative determination of igm response to hepatitis b virus core antigen in human pediatric (2 through 21 years) and adult serum and plasma (edta or lithium or sodium heparinized) using the advia centaur cp system. The assay uses recombinant hbc antigen. This assay may be used in combination with other hepatitis b virus (hbv) marker assays to define the clinical status of known hbv infected patients or can be combined with other hbv, hav (hepatitis a virus), and hcv (hepatitis c virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age. Assay performance characteristics have not been established when the advia centaur hbc igm assay is used in conjunction with other manufacturers' assays for specific hbv serological markers. Advia centaur® hbc igm quality control materialsfor monitoring the performance of the hbc igm assay using the advia centaur® systems. The performance of the hbc igm quality control material has not been established with any other anti-hbc igm assays.

DeviceADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
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
Date Received2016-07-05
Decision Date2016-12-25
PMAP030040
SupplementS011
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516

Supplemental Filings

Supplement NumberDateSupplement Type
P030040Original Filing
S021 2022-03-22 30-day Notice
S020 2021-04-01 30-day Notice
S019 2020-12-22 Real-time Process
S018 2020-07-31 30-day Notice
S017 2020-03-09 30-day Notice
S016 2020-02-21 30-day Notice
S015 2019-02-01 30-day Notice
S014 2018-08-15 Normal 180 Day Track No User Fee
S013 2018-07-19 Real-time Process
S012 2017-06-16 Normal 180 Day Track
S011 2016-07-05 Normal 180 Day Track
S010 2015-06-11 30-day Notice
S009 2015-05-14 Normal 180 Day Track
S008 2012-03-26 Normal 180 Day Track No User Fee
S007 2010-02-18 30-day Notice
S006 2009-05-18 Normal 180 Day Track
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 2008-08-11 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00630414978017 P030040 000
00630414597805 P030040 000
00630414470504 P030040 000
00630414597799 P030040 002
00630414470498 P030040 002
00630414301266 P030040 002

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