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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 PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantOrtho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester, NY 14626
PMA NumberP010021
Supplement NumberS016
Date Received03/30/2009
Decision Date07/15/2009
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISION OF THE INTENDED USE TO INCLUDE USE OF THE VITROS 5600INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE ANTI-HCV ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR AND ISINDICATED FOR:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK:FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING THE VITROSECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THEVITROS 5600 INTEGRATED SYSTEM. THREE RECOMBINANT HEPATITIS C VIRUS ENCODED ANTIGENS ARE USED.ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HEPATITIS C VIRUS, (STATE OR ASSOCIATED DISEASE NOT DETERMINED), IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FORHEPATITIS C INFECTION. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS C INFECTION INPREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HCV DURING THE PRENATALPERIOD.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE IN VITROQUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING VITROS ANTI-HCV REAGENT PACKS.THE VITROS ANTI-HCV CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQIMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK.
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