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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantOrtho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101
PMA NumberP000044
Supplement NumberS020
Date Received02/02/2009
Decision Date10/23/2009
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISION OF THE INTENDED USE TO INCLUDE USE OF THE VITROS 5600 INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE VITROS HBSAG ASSAY AND THE VITROS HBSAG CONFIRMATORY KIT. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR AND VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KIT AND IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK:FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM ANDPLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTICSYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE AND CHRONIC HEPATITIS B. IN ADDITION, THIS ASSAYMAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING IIBV DURING THE PERINATAL PERIOD.VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRALOR: FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE IN VITROQUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA USING VITROS HBSAG REAGENT PACKS. THE VITROS HBSAG CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTICSYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTSANTI-HBC REAGENT PACKS.(SEE APPROVAL ORDER FOR ADDITIONAL APPROVAL INFORMATION)
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