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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.
 
DeviceAlinity m HR HPV
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP230003
Date Received01/31/2023
Decision Date11/01/2023
Product Code MAQ 
Docket Number 23M-4997
Notice Date 11/16/2023
Advisory Committee Microbiology
Clinical TrialsNCT04746872
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Alinity m HR HPV is a qualitative in vitro test for the detection of Human Papillomavirus DNA in cervical specimens collected by a health care professional using an endocervical brush/spatula placed in ThinPrep PreservCyt Solution or an endocervical broom placed in SurePath Preservative Fluid. This test identifies high-risk (HR) HPV types 16, 18, 45, while reporting the concurrent detection of the other HR genotypes (31/33/52/58) and (35/39/51/56/59/66/68).Alinity m HR HPV is indicated for use in routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing(adjunctive screening) with cytology, and HPV primary screening of women to assess the risk for cervical pre-cancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S016 S017 
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