ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS

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

FDA Premarket Approval P010054 S001

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 addition of a new instrument platform, and changing the assay from a qualitative assay to a quantitative assay. The device, as modified, will be marketed under the trade name elecsys anti-hbs immunoassay and elecsys precicontrol anti-hbs and is indicated: elecsys anti-hbs immunoassay -for the in vitro quantitative determination of total antibodies to the hepatitis b surface antigen (hbsag) in human serum and plasma (edta). The electrochemiluminescence immunoassay? Eclia? Is intended for use on the roche elecsys 2010 and modular analytics e170 (elecsys module) immunoassay analyzers. Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results maybe 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. The detection of anti-hbs is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection. Elecsys precicontrol anti-hbs - for the quality control of the elecsys anti-hbs immunoassay on the elecsys 2010 and modular analytics e170 immunoassay analyzers. The performance of elecsys precicontrol anti-hbs has not been established with any other anti-hbs assay.

DeviceELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS
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)
ApplicantROCHE DIAGNOSTICS CORP.
Date Received2004-12-22
Decision Date2007-03-13
PMAP010054
SupplementS001
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250

Supplemental Filings

Supplement NumberDateSupplement Type
P010054Original Filing
S042 2021-12-02 30-day Notice
S041 2021-11-29 30-day Notice
S040 2018-10-26 Normal 180 Day Track No User Fee
S039 2018-10-09 30-day Notice
S038 2018-09-04 Normal 180 Day Track
S037 2018-04-27 Real-time Process
S036 2018-04-17 Real-time Process
S035 2018-03-01 Real-time Process
S034 2018-02-01 Normal 180 Day Track No User Fee
S033
S032 2017-10-11 Real-time Process
S031 2017-08-03 30-day Notice
S030 2017-05-24 30-day Notice
S029 2016-10-26 30-day Notice
S028 2016-02-16 30-day Notice
S027 2016-01-27 30-day Notice
S026 2016-01-27 135 Review Track For 30-day Notice
S025 2015-10-07 30-day Notice
S024 2014-11-25 30-day Notice
S023 2014-04-04 Real-time Process
S022 2013-04-09 Real-time Process
S021 2012-11-30 30-day Notice
S020
S019 2012-02-29 30-day Notice
S018 2012-01-31 135 Review Track For 30-day Notice
S017 2011-10-11 Normal 180 Day Track
S016 2011-08-29 135 Review Track For 30-day Notice
S015 2011-07-12 30-day Notice
S014 2011-05-17 Normal 180 Day Track No User Fee
S013 2011-04-11 30-day Notice
S012 2010-05-27 30-day Notice
S011 2009-12-22 Real-time Process
S010 2008-09-02 30-day Notice
S009 2008-06-09 Real-time Process
S008 2008-04-30 Normal 180 Day Track
S007 2007-09-04 Normal 180 Day Track
S006
S005 2006-07-11 Special (immediate Track)
S004 2006-06-13 Real-time Process
S003 2005-10-28 Real-time Process
S002 2005-09-15 Special (immediate Track)
S001 2004-12-22 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04015630910908 P010054 000
04015630919420 P010054 000
04015630999286 P010054 001
07613336159781 P010054 034
07613336154014 P010054 038
07613336159804 P010054 038
07613336159798 P010054 038

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