SIH · Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
Microbiology · 21 CFR 866.2920 · Class 2
Overview
| Product Code | SIH |
|---|---|
| Device Name | Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay |
| Regulation | 21 CFR 866.2920 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254121 | Colli-Pee•Dx Urine Collection Kit | DNA Genotek, Inc. | Jun 10, 2026 | SESE |
Top Applicants
- DNA Genotek, Inc. — 1 clearance
