# K254121: Colli-Pee•Dx Urine Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: DNA Genotek, Inc.
- Decided: Jun 10, 2026 after 173 days
- Product code: SIH (Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti 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 5.

## Indications for use
The Colli-Pee™ •Dx Urine Collection Kit is a device for the self-collection of first-void urine for the purpose of collecting and transporting specimens for use in an FDA cleared STI molecular assay with which the device has been validated. Colli-Pee™•Dx Urine Collection Kit can be used at-home or in any private setting.

Source page: https://510kreport.com/device/K254121
Methodology: https://510kreport.com/methodology