Not Cleared Direct

DEN240045 - Teal Wand (FDA 510(k) Clearance)

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

DEN240045 · Teal Health, Inc. · Microbiology device
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May 2025
Decision
255d
Days
Class 2
Risk

DEN240045 is an FDA 510(k) submission (not cleared) for the Teal Wand. Classified as Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay (product code SEP), Class II - Special Controls.

Submitted by Teal Health, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on May 9, 2025 after a review of 255 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2920 - 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. Elevated predicate reliance profile. With 255 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 Teal Health, Inc. devices

Submission Details

510(k) Number DEN240045 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 27, 2024
Decision Date May 09, 2025
Days to Decision 255 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 102d · This submission: 255d
Pathway characteristics

Device Classification

Product Code SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2920
Definition A Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Hpv Testing Is A Device Intended For Use By Lay Users In Home Settings Or Similar Environments For The Collection And Transportation Of Vaginal Specimens For Testing Using An Approved Hpv Molecular Assay With Which The Device Has Been Validated.
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.