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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
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP080026
Date Received10/16/2008
Decision Date08/13/2010
Product Code
MKT[ Registered Establishments with MKT ]
Docket Number 10M-0519
Notice Date 10/01/2010
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the abbottrealtime hbv. The device is indicated for:abbott realtime hbv assay:abbott realtime hbv assay is an in vitro polymerase chain reaction (pcr) assay for use with the abbott m2000 systemdna reagents and with the abbott m200sp and m2ooort instrumentsfor the quantitation of hepatitis b virus (hbv) dna in human serum or plasma (edta) from chronically hbv-infected individuals. The assay is intended for use as an aid in themanagement 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 abbott realtime hbv assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance for determining the clinical stage of hbv infection has not been established. Clinical performancecharacteristics have been established for individuals treated with adefovir dipivoxil. This assayis not intended for use as a screening test in blood or blood products for hbv or as a diagnostic test to confirm the presence of hbv infection. Abbott realtime hbv assay control kit:the abbott realtime hbv controls arc used to establish run validity of the abbott realtimehbv assay when used for the quantitation of hepatitis b virus (hbv) dna in human serumand plasma (edta) from hbv infected individuals. Abbott realtime hbv assay calibrator kit:the abbott realtime hbv calibrators are for calibration of the abbott realtime hbv assay when used for the quantitation determination of hepatitis b virus (hbv) dna in human serum and plasma (edta) from hbv infected individuals.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S002 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S016 S017 S018