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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/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.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
Generic NameQualitative and Quantitative Hepatitis B Virus Antibody assays
Regulation Number866.3173
ApplicantOrtho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester, NY 14626
PMA NumberP100001
Date Received01/29/2010
Decision Date07/20/2011
Reclassified Date10/20/2025
Product Code SEI 
Docket Number 11M-0563
Notice Date 08/01/2011
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, CALIBRATOR AND CONTROLS. THIS DEVICE IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF CHRONIC HEPATITIS AND THOSE WHO HAVE RECOVERED FROM HBV INFECTION, USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS. FURTHER ASSESSMENT OF HBV INFECTION (BIOCHEMICAL, SEROLOGICAL AND/OR NUCLEIC ACID TESTING) IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. VITROS ANTI-HBE TEST PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS WHEN USED WITH THE VITROS ANTI-HBE TEST FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE). VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CONTROLS FOR USE IN MONITORING THE PERFORMANCE OF THE VITROS ANTI-HBE TEST WHEN USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 
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