Cleared Traditional

K183648 - APAS Independence with Urine Analysis Module (FDA 510(k) Clearance)

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

K183648 · Clever Culture Systems AG · Microbiology device
May 2019
Decision
140d
Days
Class 2
Risk

K183648 is an FDA 510(k) clearance for the APAS Independence with Urine Analysis Module. Classified as Microbial Colony Image Assessment System (product code PPU), Class II - Special Controls.

Submitted by Clever Culture Systems AG (Bach, CH). The FDA issued a Cleared decision on May 15, 2019 after a review of 140 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K183648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date May 15, 2019
Days to Decision 140 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 174d · This submission: 140d
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.