510(k) K254121
K254121 is an FDA 510(k) premarket notification submitted by DNA Genotek, Inc. for the device "Colli-PeeDx Urine Collection Kit". The FDA issued a decision of Substantially Equivalent on Jun 10, 2026. The device falls under product code SIH (Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay), a Class II device regulated under 21 CFR 866.2920. DNA Genotek, Inc. has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 10, 2026
- Date Received
- Dec 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
- Device Class
- Class II
- Regulation Number
- 866.2920
- Review Panel
- MI
- Submission Type
- 510(k)
A device for home collection and transport of specimens by lay users for use in a cleared non-viral STI molecular assay is a device intended for use by lay users in home settings or similar environments for the collection and transportation of specimens for testing using a cleared non-viral STI molecular assay with which the device has been validated.