510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254121Substantially Equivalent

Colli-Pee•Dx Urine Collection Kit

DNA Genotek Inc., Ottawa, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254121 is the FDA 510(k) clearance record for Colli-Pee•Dx Urine Collection Kit, a class II device, cleared for DNA Genotek, Inc. on under FDA product code SIH (Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay). FDA's definition for product code SIH reads: "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...". FDA records list 8 510(k) clearances for DNA Genotek, Inc., from to . As of , FDA records show no recalls naming K254121.

Clearance record

Decision date
Received
(173 days to decision)
Product code
SIH Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
Regulation
21 CFR 866.2920
Device class
Class II
Review panel
Microbiology
Applicant
DNA Genotek, Inc. 3000 - 500 Palladium Dr., Ottawa, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SIH

Trailing 12 months
1 clearance under product code SIH in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SIH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260