SEP · Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

Microbiology · 21 CFR 866.2920 · Class 2

Overview

Identification

The Teal Wand is a single patient use device intended for a person to self-collect vaginal specimens. The device consists of a plastic casing containing a swab-like projection with a foam sponge designed to collect the vaginal specimen. It includes an empty polypropylene specimen vial, nitrile gloves, a pen, Instructions for Use, a rigid safety bag, and a return mailer. The device is used by inserting it into the vaginal canal, deploying petals to expose the collection sponge, rotating the dial to collect cells, and retracting the sponge for withdrawal. The specimen is transported dry to a laboratory for downstream high-risk HPV molecular testing.

Classification Rationale

Class II (special controls). The device is subject to the special controls identified in the De Novo classification order, as general controls alone are insufficient to mitigate the risks of failure to collect and transport specimens, insufficient specimen quantity and quality, and injury to lay users.

Recent Cleared Devices (2 of 2)

Top Applicants

• Becton, Dickinson and Company — 1 clearance
• Teal Health, Inc. — 1 clearance