FDA Product Code PPU: Microbial Colony Image Assessment System
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.
Leading manufacturers include Copan Wasp Srl.
FDA 510(k) Cleared Microbial Colony Image Assessment System Devices (Product Code PPU)
About Product Code PPU - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PPU since 2016, with 2 receiving FDA clearance (average review time: 226 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PPU have taken an average of 251 days to reach a decision - up from 214 days historically. Manufacturers should account for longer review timelines in current project planning.
PPU devices are reviewed by the Microbiology panel. Browse all Microbiology devices →