DeviceClearance

Product code SEP— Microbiology

Onclarity Self-Collection Kit

Classification name
Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Device class
Class 2
Regulation
21 CFR 866.2920
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SEP under 21 CFR 866.2920, via openFDA

Market context for product code SEP

FDA has cleared 2 devices under product code SEP between 2025 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SEP

Recent clearances under product code SEP

Data sourced from openFDA. This site is unofficial and independent of the FDA.