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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.
 
DeviceAPTIMA HCV QUANT DX ASSAY
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantHOLOGIC, INC.
10210 Genetic Center Dr
SAN DIEGO, CA 92121
PMA NumberP160023
Date Received07/08/2016
Decision Date02/13/2017
Reclassified Date 12/22/2021
Product Code MZP 
Docket Number 17M-0971
Notice Date 02/27/2017
Advisory Committee Microbiology
Clinical TrialsNCT02068963
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Aptima HCV Quant Dx. This device is indicated for: The Aptima HCV Quant Dx Assay is a real-time transcription mediated amplification test (TMA) used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals. Plasma may be prepared in ethylenediaminetetraacetic acid (EDTA), anticoagulant citrate dextrose (ACD) solution, and plasma preparation tubes (PPT). Serum may be prepared in serum tubes and serum separator tubes (SST). Specimens are tested using the Panther system for automated specimen processing, amplification, detection, and quantitation. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay. The Aptima HCV Quant Dx Assay is indicated for use as an aid in the diagnosis of active HCV infection in the following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and, therefore, is evidence of active infection. Detection of HCV RNA does not discriminate between acute and chronic state of infection. The Aptima HCV Quant Dx Assay is also indicated for use as an aid in the management of HCV infected patients undergoing HCV antiviral drug therapy. The assay can be used to measure HCV RNA levels periodically prior to, during, and after treatment to determine sustained virological response (SVR) or nonsustained virological response (NSVR). Assay performance characteristics have been established for individuals infected with HCV and treated with certain direct acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other therapies are used. The results from the Aptima HCV Quant Dx Assay must be interpreted within the context of all relevant clinical and laboratory findings. The Aptima HCV Quant Dx Assay is not approved for use as a screening test for the presence of HCV RNA in blood or blood products.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S001 S006 S013 S009 S004 S007 S003 S005 S010 S016 
S014 S015 S008 S017 S011 S012 S019 
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