Not Cleared Direct

DEN240020 - Visby Medical Women's Sexual Health Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240020 · Visby Medical, Inc. · Microbiology device
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Mar 2025
Decision
319d
Days
Class 2
Risk

DEN240020 is an FDA 510(k) submission (not cleared) for the Visby Medical Women's Sexual Health Test. Classified as Test For Detection Of Microorganism(s) Causing Sexually Transmitted Infections Performed By Lay Users (product code SEA), Class II - Special Controls.

Submitted by Visby Medical, Inc. (San Jose, US). The FDA issued a Not Cleared (DENG) decision on March 28, 2025 after a review of 319 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3386 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 319 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Visby Medical, Inc. devices

Submission Details

510(k) Number DEN240020 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 13, 2024
Decision Date March 28, 2025
Days to Decision 319 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 102d · This submission: 319d
Pathway characteristics

Device Classification

Product Code SEA Test For Detection Of Microorganism(s) Causing Sexually Transmitted Infections Performed By Lay Users
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3386
Definition This Device Is An In Vitro Diagnostic Device For The Detection And/or Differentiation Of Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections In Clinical Specimens For Use In Home Settings, Or Similar Environments. The Test Is Intended For Prescription Or Over-the-counter Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.