Cleared Traditional

Colibri System

K193138 · Copan Wasp Srl · Microbiology
Dec 2021
Decision
775d
Days
Class 2
Risk

About This 510(k) Submission

K193138 is an FDA 510(k) clearance for the Colibri System, a Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry (Class II — Special Controls, product code QQV), submitted by Copan Wasp Srl (Brescia, IT). The FDA issued a Cleared decision on December 27, 2021, 775 days after receiving the submission on November 13, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3378.

Submission Details

510(k) Number K193138 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2019
Decision Date December 27, 2021
Days to Decision 775 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QQV — Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Device Class Class II — 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).