APTIMA HCV QUANT DX ASSAY

Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus

FDA Premarket Approval P160023

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.

Pre-market Approval Supplement Details

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.

DeviceAPTIMA HCV QUANT DX ASSAY
Classification NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantHOLOGIC, INC.
Date Received2016-07-08
Decision Date2017-02-13
Notice Date2017-02-27
PMAP160023
SupplementS
Product CodeMZP
Docket Number17M-0971
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 10210 Genetic Center Dr san Diego, CA 92121
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P160023Original Filing
S019 2020-07-09 30-day Notice
S018
S017 2020-02-12 30-day Notice
S016 2019-12-23 Real-time Process
S015 2019-06-21 Normal 180 Day Track
S014 2019-05-21 30-day Notice
S013 2019-04-19 30-day Notice
S012 2019-03-27 30-day Notice
S011 2019-03-18 Real-time Process
S010 2019-02-21 30-day Notice
S009 2018-12-31 Real-time Process
S008 2018-11-29 30-day Notice
S007 2018-10-03 30-day Notice
S006 2018-08-31 30-day Notice
S005 2018-07-09 30-day Notice
S004 2018-05-09 135 Review Track For 30-day Notice
S003 2018-04-20 30-day Notice
S002 2018-03-12 30-day Notice
S001 2017-08-28 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045506800 P160023 000
15420045506794 P160023 000
15420045506787 P160023 000
15420045506800 P160023 001
15420045506794 P160023 001
15420045506787 P160023 001

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