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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.
 
DeviceAMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0
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 NumberP000010
Date Received02/23/2000
Decision Date07/05/2001
Withdrawal Date 06/30/2014
Product Code MZP 
Docket Number 02M-0082
Notice Date 02/27/2002
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE 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 A MICROWELL PLATE READER. THE 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 INFECTION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S003 S004 S005 S006 S007 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 S025 
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