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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.
 
DeviceCOBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP000012
Supplement NumberS009
Date Received01/31/2006
Decision Date06/16/2006
Withdrawal Date08/26/2016
Product Code MZP 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE EXTENSION OF THE SHELF LIFE TO 24 MONTHS OF THE HCV MASTER MIX, VERSION 2.0, A COMPONENT OF THE COBAS AMPLICOR HCV TEST, V2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLICOR HCV TEST, V2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF HCV RNA IN HUMAN SERUM OR PLASMA FROM BLOOD COLLECTED IN EDTA (EDTA PLASMA). THE TEST DETECTS BY REVERSE TRANSCRIBING TARGET HCV RNA IN COMPLIMENTARY DNA (CDNA), AMPLIFYING CDNA BY POLYMERASE CHAIN REACTION (PCR), HYBRIDIZING AMPLIFIED CDNA WITH AN OLIGONUCLEOTIDE PROBE THAT BINDS ENZYME, AND CATALYZING CONVERSION OF SUBSTRATE TO A COLORED PRODUCT THAT IS RECOGNIZED BY THE COBAS AMPLICOR ANALYZER. THE COBAS AMPLICOR HCV TEST, V2.0 IS INDICATED FOR PATIENTS WHO HAVE EVIDENCE OF LIVER DISEASE AND ANTIBODY EVIDENCE OF HCV INFECTION, AND WHO ARE SUSPECTED O BE ACTIVELY INFECTED WITH HCV.
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