Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceABBOTT REALTIME HBV ASSAY
Generic NameHepatitis Viral B DNA Detection
ApplicantABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018
PMA NumberP080026
Date Received10/16/2008
Decision Date08/13/2010
Product Code MKT 
Docket Number 10M-0519
Notice Date 10/01/2010
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 
-
-