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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 NumberS007
Date Received09/16/2005
Decision Date01/12/2006
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE REMOVAL OF THE WARNING ASSOCIATED WITH PRENATAL SCREENING AND A MODIFIED INDICATION FOR USE. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR WITH THE ADDITION OF MODEL DESIGNATIONS (ECIQ/ECI), AND IS INDICATED AS FOLLOWS: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 VITROS ECI/ECIQ IMMUNODIAGNOSTIC 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 FOR HEPATITIS C INFECTION. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS C INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HCV DURING THE PRENATAL PERIOD.
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