K193138 is an FDA 510(k) clearance for the Colibri System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3378. 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)..
| 510(k) Number | K193138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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). |