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510(k) K260184

Onclarity™ Self-Collection Kit by Becton, Dickinson and Company — Product Code SEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2026
Date Received
January 21, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Device Class
Class II
Regulation Number
866.2920
Review Panel
MI
Submission Type

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.

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