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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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IsoPSA Assay PAS


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General
Study Status Study Pending
Application Number /
Requirement Number		 P200048 / PAS001
Date Original Protocol Accepted 11/28/2025
Date Current Protocol Accepted 11/28/2025
Study Name IsoPSA Assay PAS
Device Name IsoPSA Assay
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives A prospective, single-blind, multi-site post-approval study of the IsoPSA Assay in an African American population.
Study Population African American population
Sample Size At least 250 African American subjects resulting in at least 50 African American subjects with an IsoPSA Index less than or equal to 6.0.
Key Study Endpoints Clinical performance measures of IsoPSA Assay with three outputs for Target Condition = (Grade Group greater than or equal to 2, Geason Score greater than or equal to 7) and an Assessment of the TC = prostate biopsy.
Follow-up Visits and Length of Follow-up No follow-up


IsoPSA Assay PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/29/2026    
1 year report 11/28/2026    
2 year report 11/28/2027    
3 year report 11/27/2028    
4 year report 11/27/2029    


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

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