COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus

FDA Premarket Approval P060030

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 the cobasampliprep/cobas taqman hcv test. This device is an in vitro nucleic acid amplification lestfor the quantitation of hepatitis c viral (hcv) rna in human plasma or serum of hcv-infectedindividuals using the cobas ampliprep instrument for automated specimen processing and thecobas taqman analyzer or the cobas taqman 48 analyzer for automated amplification anddetection. Specimens containing hcv genotypes 1 - 6 have been validated for quantitation inthe assay. The cobas ampliprep/cobas taqman hcv test is intended for use as an aid in themanagement of hcv-infected individuals undergoing anti-viral therapy. The assay measureshcv rna levels at baseline and during treatment and can be utilized to predict sustained andnon-sustained virological response to hcv therapy. The results from the cobasampiprep/cobas taqman hcv test must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a plus ribavirin. No information is available on the assay's predictive value when other therapies are used. Assay performance for determining the slate of hcv infection has not been established. "

DeviceCOBAS AMPLIPREP/COBAS TAQMAN HCV TEST
Classification NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantRoche Molecular Systems, Inc.
Date Received2006-10-27
Decision Date2008-10-30
Notice Date2009-01-27
PMAP060030
SupplementS
Product CodeMZP
Docket Number09M-0033
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
P060030Original Filing
S086 2021-06-14 30-day Notice
S085 2021-02-23 30-day Notice
S084 2020-07-27 30-day Notice
S083 2020-04-17 30-day Notice
S082 2020-01-23 30-day Notice
S081 2019-10-08 30-day Notice
S080 2019-09-20 30-day Notice
S079 2019-08-16 30-day Notice
S078 2019-07-15 Special (immediate Track)
S077 2019-05-23 Real-time Process
S076 2019-04-24 30-day Notice
S075 2019-04-10 30-day Notice
S074 2019-04-08 30-day Notice
S073 2019-03-20 30-day Notice
S072 2018-12-14 30-day Notice
S071 2018-11-13 30-day Notice
S070 2018-11-09 30-day Notice
S069 2018-08-21 30-day Notice
S068 2018-07-27 30-day Notice
S067 2018-06-29 30-day Notice
S066 2018-06-08 30-day Notice
S065 2018-06-04 30-day Notice
S064 2018-04-16 30-day Notice
S063 2018-04-16 30-day Notice
S062 2018-03-01 30-day Notice
S061 2017-11-14 30-day Notice
S060 2017-09-26 30-day Notice
S059 2017-08-07 30-day Notice
S058 2017-07-14 30-day Notice
S057 2017-07-14 30-day Notice
S056 2017-04-21 Special (immediate Track)
S055 2016-09-22 30-day Notice
S054 2016-08-16 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 2015-11-17 Real-time Process
S048 2015-08-31 Normal 180 Day Track
S047 2015-04-09 30-day Notice
S046 2015-03-13 30-day Notice
S045 2015-02-25 Real-time Process
S044 2014-12-19 30-day Notice
S043 2014-07-28 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 2014-02-03 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 2013-07-26 30-day Notice
S032 2013-05-09 30-day Notice
S031 2012-11-16 Real-time Process
S030 2012-11-06 Real-time Process
S029 2012-09-13 30-day Notice
S028 2012-08-15 30-day Notice
S027 2012-07-02 Normal 180 Day Track
S026 2012-05-30 Real-time Process
S025 2012-03-29 Normal 180 Day Track No User Fee
S024 2011-12-12 135 Review Track For 30-day Notice
S023 2011-09-12 30-day Notice
S022 2011-08-24 30-day Notice
S021 2011-07-01 Normal 180 Day Track
S020 2011-05-31 Normal 180 Day Track No User Fee
S019
S018 2011-04-07 Special (immediate Track)
S017 2011-03-01 30-day Notice
S016 2011-03-01 135 Review Track For 30-day Notice
S015 2011-02-08 30-day Notice
S014 2010-08-25 30-day Notice
S013
S012 2010-08-05 30-day Notice
S011
S010 2010-05-03 30-day Notice
S009 2010-03-01 30-day Notice
S008 2010-01-08 30-day Notice
S007 2009-12-24 30-day Notice
S006 2009-12-22 Normal 180 Day Track
S005 2009-09-15 30-day Notice
S004 2009-07-02 30-day Notice
S003 2009-04-28 30-day Notice
S002 2008-12-05 30-day Notice
S001 2008-11-14 30-day Notice

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