Cleared Traditional

Colibr?

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

About This 510(k) Submission

K223245 is an FDA 510(k) clearance for the Colibr?, 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 March 20, 2023, 151 days after receiving the submission on October 20, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3378.

Submission Details

510(k) Number K223245 FDA.gov
FDA Decision Cleared 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

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).