Cleared Traditional

K251511 - PhenoMATRIX (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251511 · Copan Wasp Srl · Microbiology device
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Jan 2026
Decision
251d
Days
Class 2
Risk

K251511 is an FDA 510(k) clearance for the PhenoMATRIX. Classified as Microbial Colony Image Assessment System (product code PPU), Class II - Special Controls.

Submitted by Copan Wasp Srl (Brescia, IT). The FDA issued a Cleared decision on January 22, 2026 after a review of 251 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2190 - the FDA microbiology device framework. 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.

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Submission Details

510(k) Number K251511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2025
Decision Date January 22, 2026
Days to Decision 251 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 102d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PPU Microbial Colony Image Assessment System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2190
Definition A Microbial Colony Image Assessment System Is An Instrument That Is Intended To Assess The Presence Or Absence Of Microbial Colonies On Solid Microbiological Culture Medium, And To Interpret Their Number, Phenotypic And Morphologic Characteristics. This Device Type Provides A Semi-quantitative Assessment Of Colony Counts That Are Used As An Aid In The Diagnosis Of Urinary Tract Infection. All Urine Culture Plates That Are Identified As Positive For Growth By The Apas Compact, When Using Its Urine Analysis Module, Must Be Reviewed By A Trained Microbiologist.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.