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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.
 
DeviceABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
Generic NameAssay, genotyping, hepatitis c virus
Regulation Number866.3170
ApplicantABBOTT MOLECULAR
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018
PMA NumberP120012
Date Received07/12/2012
Decision Date06/20/2013
Reclassified Date 12/22/2021
Product Code OBF 
Docket Number 13M-0758
Notice Date 06/24/2013
Advisory Committee Microbiology
Clinical TrialsNCT00351403
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, AND URACIL-GLYCOSYLASE(UNG). THIS DEVICE IS INDICATED FOR: ABBOTT REALTIME HCV GENOTYPE IITHE ABBOTT REALTIME HCV GENOTYPE II IS AN IN VITRO REVERSE TRANSCRIPTION-POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR USE WITH THE ABBOTT MSAMPLE PREPARATION SYSTEM REAGENTS AND WITH THE ABBOTT M2000SP AND M2000RT INSTRUMENTS FOR THE QUALITATIVE IDENTIFICATION OFHEPATITIS C VIRUS (HCV) GENOTYPES 1, 1A, 1B, AND 2 - 5 IN PLASMA OR SERUM FROM INDIVIDUALS CHRONICALLY INFECTED WITH HCV.THE ABBOTT REALTIME HCV GENOTYPE II IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED INDIVIDUALS AND IN GUIDING THE SELECTION OF THERAPEUTIC TREATMENT INDICATED FOR THE ABOVE LISTED GENOTYPES. THE ASSAY IS INTENDED FOR USE ON PATIENTS WHO ARE CHRONICALLY INFECTED WITH HCV, ARE BEING CONSIDERED FOR ANTIVIRAL TREATMENT, AND ARE POSITIVE FOR HCV RNA. THE ABBOTT REALTIME HCV GENOTYPE II ASSAY IS NOT FOR SCREENING BLOOD, PLASMA, SERUM OR TISSUE DONORS FOR HCV. ABBOTT REALTIME HCV GENOTYPE II CONTROL KITTHE ABBOTT REALTIME HCV GENOTYPE II CONTROLS ARE USED TO ESTABLISH RUN VALIDITY OF THE ABBOTT REALTIME HCV GENOTYPE II ASSAY WHEN USED FOR DETERMINING THE GENOTYPE(S) OF HEPATITIS C VIRUS (HCV) IN PLASMA OR SERUM FROM INDIVIDUALS CHRONICALLY INFECTED WITH HCV. URACIL-N-GLYCOSYLASE (UNG) THE URACIL-N-GLYCOSYLASE (UNG) PROCEDURE IS TO BE USED IN CONJUNCTION WITH ABBOTT REALTIME HCV GENOTYPE II ASSAY AS AN OPTIONAL CONTAMINATION CONTROL FOR CUSTOMER LABORATORIES THAT ARE CURRENTLY USING OR HAVE PREVIOUSLY USED AMPLIFICATION TECHNOLOGIES THATINCORPORATE URACIL INTO THE AMPLIFICATION PRODUCT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 
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