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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCOBAS AMPLICOR (TM) 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 94588-0900
PMA NumberP000012
Date Received02/29/2000
Decision Date07/03/2001
Withdrawal Date 08/26/2016
Product Code MZP 
Docket Number 02M-0083
Notice Date 02/27/2002
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0. THE DEVICE 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 INTO 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 TO BE ACTIVELY INFECTED WITH HCV. DETECTION OF HCV RNA INDICATES THAT THE VIRUS IS REPLICATING AND THEREFORE IS EVIDENCE OF ACTIVE HCV INFECTION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S012 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S031 S032 S033 S034 S035 S036 S038 S039 S040 
S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 
S053 S054 S055 S056 
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