Not Cleared Direct

DEN150059 - APAS Compact with Urine Analysis Module (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150059 · Clever Culture Systems AG · Microbiology device
Oct 2016
Decision
287d
Days
Class 2
Risk

DEN150059 is an FDA 510(k) submission (not cleared) for the APAS Compact with Urine Analysis Module. Classified as Microbial Colony Image Assessment System (product code PPU), Class II - Special Controls.

Submitted by Clever Culture Systems AG (Baech, CH). The FDA issued a Not Cleared (DENG) decision on October 6, 2016 after a review of 287 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 287 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

Submission Details

510(k) Number DEN150059 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 24, 2015
Decision Date October 06, 2016
Days to Decision 287 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 174d · This submission: 287d
Pathway characteristics

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.