IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS

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

FDA Premarket Approval P010052 S004

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 immulite/ immulite 1000 andimmulite 2000 anti hbs assay. The device is indicated for:immulite/ immulite 1000for in vitro diagnostic use with the immulite or immulite 1000 analyzers for thequalitative and quantitative measurement of total antibodies to the hepatitis b surface antigen(anti-hbs) in human serum and plasma (heparinized). Assay results may be used as an aid in thedetermination of susceptibility to hepatitis b virus (hbv) infection for 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 withhbv infection. A reactive assay result will allow a differential diagnosis in individualsdisplaying signs and symptoms of hepatitis in whom etiology is unknown. Immulite 2000for in vitro diagnostic use with the immulite 2000 systems automated immunoassayanalyzers for the qualitative and quantitative measurement of total antibodies to the hepatitis bsurface antigen (anti-hbs) in human serum and plasma (heparinized). Assay results may be usedas an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following i-ibv 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 differentialdiagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology isunknown.

DeviceIMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS
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 Products, LTD
Date Received2008-02-25
Decision Date2009-12-16
PMAP010052
SupplementS004
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 Products, LTD glyn Rhonwy llanberis, Caernarfon LL55

Supplemental Filings

Supplement NumberDateSupplement Type
P010052Original Filing
S016 2022-09-15 30-day Notice
S015
S014 2020-08-12 30-day Notice
S013 2019-11-25 30-day Notice
S012 2014-11-28 135 Review Track For 30-day Notice
S011 2011-12-19 135 Review Track For 30-day Notice
S010 2011-08-16 30-day Notice
S009 2011-08-08 30-day Notice
S008 2011-02-18 Real-time Process
S007 2009-11-02 Normal 180 Day Track No User Fee
S006
S005 2008-11-10 Normal 180 Day Track No User Fee
S004 2008-02-25 Normal 180 Day Track
S003 2005-08-17 Special (immediate Track)
S002
S001 2002-11-20 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00630414982182 P010052 001
00630414970998 P010052 001

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