COBAS TAQMAN HBV TEST

Hepatitis Viral B Dna Detection

FDA Premarket Approval P050028

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for cobas taqman hbv test for use with the high pure system. This device is indicated for: the cobas taqman hbv test for use with the high pure system is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus (hbv) dna in human serum or plasma (edta), using the high pure viral nucleic acid kit for manual specimen preparation and the cobas taqman 48 analyzer for automated amplification and detection. The test is intended for use as an aid in the management of patients with chronic hbv infection undergoing anti-viral therapy. The assay can be used to measure hbv dna levels at baseline and during treatment to aid in assessing response to treatment. The results from the cobas taqman hbv test must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established for individuals treated with adefovir dipivoxil. Assay performance for determining the state of hbv infection has not been established. The cobas taqman hbv test is not intended for use as a screening test for blood or blood products for the presence of hbv or as a diagnostic test to confirm the presence of hbv infection.

DeviceCOBAS TAQMAN HBV TEST
Classification NameHepatitis Viral B Dna Detection
Generic NameHepatitis Viral B Dna Detection
ApplicantRoche Molecular Systems, Inc.
Date Received2005-08-02
Decision Date2008-09-04
Notice Date2008-09-11
PMAP050028
SupplementS
Product CodeMKT
Docket Number08M-0501
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P050028Original Filing
S086 2022-10-21 30-day Notice
S085 2021-06-14 30-day Notice
S084 2021-02-23 30-day Notice
S083 2020-07-27 30-day Notice
S082 2020-04-17 30-day Notice
S081 2020-01-23 30-day Notice
S080 2019-10-08 30-day Notice
S079 2019-09-20 30-day Notice
S078 2019-08-16 30-day Notice
S077 2019-07-15 Special (immediate Track)
S076 2019-04-24 30-day Notice
S075 2019-04-08 30-day Notice
S074 2019-03-20 30-day Notice
S073 2018-12-14 30-day Notice
S072 2018-11-13 30-day Notice
S071 2018-11-09 30-day Notice
S070 2018-08-21 30-day Notice
S069 2018-07-27 30-day Notice
S068 2018-06-29 30-day Notice
S067 2018-06-08 30-day Notice
S066 2018-06-04 30-day Notice
S065 2018-05-21 30-day Notice
S064 2018-04-16 30-day Notice
S063 2018-04-16 30-day Notice
S062 2018-04-16 30-day Notice
S061 2018-03-01 30-day Notice
S060 2017-11-14 30-day Notice
S059 2017-10-30 30-day Notice
S058 2017-09-26 30-day Notice
S057 2017-07-14 30-day Notice
S056 2017-07-14 30-day Notice
S055 2017-04-21 Special (immediate Track)
S054 2016-09-22 30-day Notice
S053 2016-07-19 30-day Notice
S052 2016-07-08 30-day Notice
S051 2016-04-18 30-day Notice
S050 2016-04-07 30-day Notice
S049
S048 2015-11-17 Real-time Process
S047 2015-06-24 30-day Notice
S046 2015-04-09 30-day Notice
S045 2015-03-13 30-day Notice
S044 2015-02-25 Real-time Process
S043 2014-12-19 30-day Notice
S042 2014-03-31 30-day Notice
S041 2014-03-18 30-day Notice
S040 2014-02-18 30-day Notice
S039 2013-12-26 30-day Notice
S038 2013-12-13 30-day Notice
S037 2013-09-09 30-day Notice
S036 2013-09-09 30-day Notice
S035 2013-08-14 30-day Notice
S034 2013-08-09 30-day Notice
S033 2013-05-28 30-day Notice
S032 2013-05-09 30-day Notice
S031 2013-04-08 30-day Notice
S030 2013-02-19 Real-time Process
S029 2012-11-16 Real-time Process
S028 2012-11-06 Real-time Process
S027 2012-09-13 30-day Notice
S026 2012-08-15 30-day Notice
S025 2012-05-30 Real-time Process
S024 2012-03-29 Normal 180 Day Track No User Fee
S023 2011-12-12 135 Review Track For 30-day Notice
S022 2011-09-12 30-day Notice
S021 2011-09-01 Special (immediate Track)
S020 2011-07-01 Normal 180 Day Track
S019 2011-05-31 Normal 180 Day Track No User Fee
S018
S017 2011-03-08 135 Review Track For 30-day Notice
S016 2011-03-01 30-day Notice
S015 2011-03-01 135 Review Track For 30-day Notice
S014
S013 2011-02-08 30-day Notice
S012 2010-11-08 30-day Notice
S011 2010-09-22 135 Review Track For 30-day Notice
S010
S009
S008 2010-08-05 30-day Notice
S007 2010-01-08 30-day Notice
S006 2009-12-24 30-day Notice
S005 2009-07-02 30-day Notice
S004 2009-07-01 Normal 180 Day Track
S003 2008-12-05 30-day Notice
S002 2008-10-31 30-day Notice
S001 2008-10-06 Real-time Process

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