Cleared Traditional

K223245 - Colibrí (FDA 510(k) Clearance)

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

K223245 · Copan Wasp Srl · Microbiology device
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Mar 2023
Decision
151d
Days
Class 2
Risk

K223245 is an FDA 510(k) clearance for the Colibrí. Classified as Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry (product code QQV), Class II - Special Controls.

Submitted by Copan Wasp Srl (Brescia, IT). The FDA issued a Cleared decision on March 20, 2023 after a review of 151 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3378 - 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.

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Submission Details

510(k) Number K223245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2022
Decision Date March 20, 2023
Days to Decision 151 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 102d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3378
Definition An Automated In Vitro Diagnostic System To Prepare Colonies Of Microorganisms Grown On Solid Culture Media From Human Specimens For Qualitative Identification And Differentiation Using Matrix-assisted Laser Desorption/ionization-time Of Flight Mass Spectrometry (maldi-tof Ms).
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.