Cleared Traditional

Colli-Pee•Dx Urine Collection Kit (K254121) - FDA 510(k) Clearance

K254121 · DNA Genotek, Inc. · Microbiology device
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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

Submission Details

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.

Device Classification

Product Code SIH
Device Class -