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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.
 
DeviceADVIA CENTAUR HCV ON CENTAUR CP
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516
PMA NumberP030056
Supplement NumberS002
Date Received08/25/2008
Decision Date08/13/2009
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HCV ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP.ADVIA CENTAUR HCV READYPACK REAGENTS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR HCV ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEDETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THEDIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS CINFECTION.ADVIA CENTAUR HCV QUALITY CONTROLS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR HCV QUALITY CONTROLS ARE INTENDED FOR IN VITRO DIAGNOSTIC USE INMONITORING THE PERFORMANCE OF THE HCV ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HCV QUALITY CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HCV ASSAY.
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