ELECSYS ANTI-HBS TEST SYSTEM

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

FDA Premarket Approval P010054 S008

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 to extend application of the elecsys hbsag and elecsys anti-hbs test systems onto the updated version of the modular analytics e170 analyzer known as the cobas e 601 analyzer. While the modular analytics modular system integrates the e170 module with clinical chemistry modules p or d, the cobas e 601 immunoassay analyzer is a component of the c6000 modular system which integrates immunology testing with the cobas c 501 clinical chemistry analyser. There have been no changes to the composition of any of te test system reagents (immunoassay, controls or confirmatory test), the application parameters, the analyzer¿s analytical measuring component or how the results are calculated. The indications for use of the two test systems remain the same.

DeviceELECSYS ANTI-HBS TEST SYSTEM
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 Received2008-04-30
Decision Date2008-10-30
PMAP010054
SupplementS008
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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