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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/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantOrtho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester, NY 14626-5101
PMA NumberP000044
Date Received11/01/2000
Decision Date04/27/2001
Reclassified Date10/20/2025
Product Code LOM 
Docket Number 01M-0226
Notice Date 05/14/2001
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 HBSAG REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNODIAGNOSTIC PRODUCTS CALIBRATOR. THE VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD. THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR IS INDICATED FOR USE IN THE CALIBRATION OF THE VITROS IMMUNODIAGNOSTIC SYSTEM FOR THE QUALITATIVE IN VITRO DETERMINATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) USING VITROS HBSAG REAGENT PACKS. THE VITROS HBSAG CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK. REFER TO THE VITROS HBSAG REAGENT PACK INSTRUCTIONS FOR USE FOR FURTHER DETAILS. THE VTIROS HBSAG CONFIRMATORY KIT IS INDICATED FOR THE QUALITATIVE CONFIRMATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) SPECIMENS THAT HAVE BEEN FOUND TO BE REPEATEDLY REACTIVE USING THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR. THE VITROS HBSAG CONFIRMATORY KIT IS FOR USE WITH THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S026 S020 S021 S027 S003 S029 S030  S025 S014 S009 S016 
S028 S031 S032 S002 S006 S007 S008 S011 S012 S013 S017 S024 
S034 S040 S033 S022 S001 S004 S005 S010 S015 S018 S023 S035 
S019 S036 S037 S038 S039 
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