Cleared Traditional

K254121 - Colli-Pee•Dx Urine Collection Kit

K254121 · DNA Genotek, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
173d
Days
-
Risk

K254121 is an FDA 510(k) clearance for the Colli-Pee•Dx Urine Collection Kit.

Submitted by DNA Genotek, Inc. (Ottawa, CA). The FDA issued a Cleared decision on June 10, 2026 after a review of 173 days - an extended review cycle.

This device falls under the Microbiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all DNA Genotek, Inc. devices

FDA 510(k) Submission Details - K254121

510(k) Number K254121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date June 10, 2026
Days to Decision 173 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 102d · This submission: 173d
Pathway characteristics
Predicate-based equivalence.

SIH Device Classification - Class ,

Product Code SIH
Device Class -