Cleared Traditional

PhenoMATRIX

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

About This 510(k) Submission

K251511 is an FDA 510(k) clearance for the PhenoMATRIX, a Microbial Colony Image Assessment System (Class II — Special Controls, product code PPU), submitted by Copan Wasp Srl (Brescia, IT). The FDA issued a Cleared decision on January 22, 2026, 251 days after receiving the submission on May 16, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2190.

Submission Details

510(k) Number K251511 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PPU — Microbial Colony Image Assessment System
Device Class Class II — 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.