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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCOBAS AMPLIPREP/COBAS TAQMAN HBV TEST
Classification Namehepatitis viral b dna detection
Generic Namecobas taqman hbv test for use with the high pure system
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP050028
Supplement NumberS004
Date Received07/01/2009
Decision Date09/09/2010
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for a device design modification that includes reagents, disposables, and instrumentation, to automate the manual sample preparation process currently used by the cobas taqman hbv test for use with the high pure system. The device, as modified, will be marketed under the trade name cobas ampliprep/ cobas taqman hbv test, v2. 0 and is indicated for: the cobas ampliprep/cobas taqman hbv test, v2. 0 is an in vitro nucleic acid amplification lest for the quantitation of hepatitis b virus (hbv) dna in human serum or plasma (edta), using the cobas ampliprep instrument for automated specimen processing and the cobas taqman analyzer or cobas taqman 48 analyzer for automated amplification and detection. This test is intended for use as an aid in the management of patients with chronic hbv infection undergoing antiviral therapy. The test 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 ampliprep/ cobas taqman1 hbv test, v2. 0 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 slate of hbv infection has not been established. The cobas ampliprep/ cobas taqman hbv test, v2. 0 is not intended for use as a screening test for the presence of hbv in blood or blood products or as a diagnostic test to confirm the presence of hbv infection.
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