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Colibri System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K193138

by Copan Wasp Srl

Identifiers

510(k) Number
K193138 FDA 510(k)
FDA Product Code
QQV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3378 FDA 510(k)
Regulation Number
866.3378 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Colibri System is an automated device for sample preparation and identification of microorganisms from cultured isolates using mass spectrometry. Classified as an automated system for microbiology, it streamlines the processing of bacterial colonies for rapid identification via MALDI-TOF technology, supporting both Gram-negative and Gram-positive bacteria.

This system is designed for microbiology laboratories and automates colony picking and microbial suspension preparation for mass spectrometry-based identification and antibiotic susceptibility testing (AST). Supplied as a reusable instrument, it is intended for use with compatible mass spectrometry platforms such as bioMérieux VITEK MS, Bruker MALDI Biotyper, and AST systems like VITEK 2 or MicroScan. Authorized under FDA 510(k) and IVDR, the device adheres to regulatory standards for microbiological diagnostics, with no specific sterility or MRI safety requirements stated.

Frequently asked questions

What types of microorganisms can the Colibri System identify, and how does it prepare samples for analysis?

The Colibri System is designed to automate the preparation and identification of both Gram-negative and Gram-positive bacteria from cultured isolates. It streamlines the process by picking bacterial colonies and preparing microbial suspensions, which are then analyzed using mass spectrometry (MALDI-TOF technology) for rapid identification. This integration with mass spectrometry platforms like bioMérieux VITEK MS or Bruker MALDI Biotyper enables efficient workflows in microbiology labs.

Is the Colibri System reusable, and how does it integrate with existing laboratory workflows?

Yes, the Colibri System is supplied as a reusable instrument, meaning it is built to be used repeatedly in microbiology laboratories. It is designed to work with compatible mass spectrometry platforms such as bioMérieux VITEK MS, Bruker MALDI Biotyper, and AST systems like VITEK 2 or MicroScan, allowing seamless integration into existing workflows for bacterial identification and antibiotic susceptibility testing.

What regulatory pathways has the Colibri System undergone, and what does this mean for its use in clinical settings?

The Colibri System has been authorized through the FDA 510(k) pathway and is compliant with the In Vitro Diagnostic Regulation (IVDR). This means it has undergone regulatory review to demonstrate substantial equivalence to existing devices and meets the necessary standards for safety and performance in microbiological diagnostics. Clinicians and labs can rely on its compliance with these regulatory frameworks when incorporating it into their workflows.

Does the Colibri System require any special handling or storage conditions?

The provided specifications do not mention any special sterility or storage requirements for the Colibri System itself, as it is a reusable instrument. However, since it is used in microbiology for sample preparation, standard laboratory hygiene practices should be followed to ensure proper maintenance and prevent contamination. Always refer to the manufacturer’s instructions for specific operational guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Colibrí™ | COPAN, Colibri Product Range Solutions | Copan, Colibrí™ FAQ - COPAN

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Copan Wasp Srl

Sources (2)

  • FDA 510(k) K193138 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026