K251511 is an FDA 510(k) clearance for the PhenoMATRIX. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.2190. 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..
| 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 |
| 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. |