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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 HBV Quant Assay
Classification Namehepatitis viral b dna detection
Generic Namehepatitis viral b dna detection
Applicant
Hologic, Inc
10210 genetic center drive
san diego, CA 92121
PMA NumberP170025
Date Received07/31/2017
Decision Date01/23/2018
Product Code
MKT[ Registered Establishments with MKT ]
Docket Number 18M-0411
Notice Date 02/02/2018
Advisory Committee Microbiology
Clinical Trials NCT02167113
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Aptima HBV Quant assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther® system.Plasma may be prepared in ethylenediaminetetraacetic acid (EDTA), anticoagulant citrate dextrose (ACD) solution, and plasma preparation tubes (PPTs). Serum may be prepared inserum tubes and serum separator tubes (SSTs). Specimens are tested using the fullyautomated Panther system for sample processing, amplification, and quantitation. Specimenscontaining HBV genotypes A, B, C, D, E, F, G, and H are validated for quantitation in the assay.The Aptima HBV Quant assay is intended for use as an aid in the management of patientswith chronic HBV infections undergoing HBV antiviral drug therapy. The assay can be usedto measure HBV DNA levels at baseline and during treatment to aid in assessing viralresponse to treatment. The results from the Aptima HBV Quant assay must be interpretedwithin the context of all relevant clinical and laboratory findings. Assay performance fordetermining the clinical stage of HBV infection has not been established. Clinicalperformance characteristics have been established for individuals treated with tenofovirdisoproxil fumarate or entecavir.The Aptima HBV Quant assay is not approved for use as a screening test for the presenceof HBV DNA in blood or blood products or as a diagnostic test to confirm the presence ofHBV infection.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 
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