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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Abbott Alinity m HR HPV US Supplemental Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P230003 S006/ PAS001
Date Original Protocol Accepted 09/10/2025
Date Current Protocol Accepted 09/10/2025
Study Name Abbott Alinity m HR HPV US Supplemental Study
Device Name Alinity m HR HPV
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The study will include 500 or more individuals with a cervix, 25 years or older, with referrals to colposcopy based on previous positive HPV test or abnormal cytology results. The study will provide additional data regarding clinical performance of the Alinity m HR HPV assay with vaginal specimens in a U.S. population. The clinical sensitivity, clinical specificity and false positive rate in detecting precancer/cancer as well as the corresponding ratio between vaginal and cervical specimens will be evaluated. Additionally, the concordance of the Alinity m HR HPV assay results between the two sepecimen types will be evaluated.
Study Population Individuals with a cervix, 25 years or older, who come to colposcopy with a referral based on previous positive HPV test or abnormal cytology results
Sample Size 500 or more
Key Study Endpoints The clinical sensitivity, clinical specificity and false positive rate in detecting precancer/cancer as well as the corresponding ratio between vaginal and cervical specimens.
The concordance of the Alinity m HR HPV Assay results between the two specimen types.
Follow-up Visits and Length of Follow-up No follow-up, unless required for standard of care (SOC) clinical care purposes


Abbott Alinity m HR HPV US Supplemental Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/11/2026    
1 year report 09/10/2026    
18 month report 03/11/2027    
2 year report 09/10/2027    
3 year report 09/09/2028    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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