# K260184: Onclarity™ Self-Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Apr 2, 2026 after 71 days
- 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: 2
- Regulation: 21 CFR 866.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN240045 (2025). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN240045: Teal Wand, Teal Health, Inc. (2025) Summary page 6.

## Indications for use
The Onclarity™ Self-Collection Kit is intended for the self-collection and transport of vaginal specimens for use with an FDA approved HPV molecular assay with which the collection device has been validated. The Onclarity™ Self-Collection Kit contains all of the necessary components for the self-collection of a vaginal specimen in a home or private setting. Specimen can be collected and shipped dry.

Source page: https://510kreport.com/device/K260184
Methodology: https://510kreport.com/methodology