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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namehepatitis viral b dna detection
Generic Namehepatitis viral b dna detection
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP050028
Date Received08/02/2005
Decision Date09/04/2008
Product Code
MKT[ Registered Establishments with MKT ]
Docket Number 08M-0501
Notice Date 09/11/2008
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S011 
S012 S013 S015 S016 S017 S019 S020 S021 S022 
S023 S024 S025 S026 S027 S028 S029 S030 S031 
S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S044 S045 S046 S047 S048 S050 
S051 S052 S053 S054