Identifiers
- 510(k) Number
- K220546 FDA 510(k)
- FDA Product Code
- LON FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1645 FDA 510(k)
- Regulation Number
- 866.1645 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Colibrí System is an Automated Antimicrobial Susceptibility Test System designed for microbiology applications. It automates the detection of antimicrobial resistance in bacterial isolates, enabling rapid and precise identification of susceptibility profiles for clinical pathogens.
This system is intended for use in clinical microbiology laboratories and is supplied as a reusable device with sterile consumables. It operates under IVDR and has received FDA 510(k) clearance as substantially equivalent, adhering to regulatory standards for antimicrobial susceptibility testing. The system supports short incubation protocols and is classified as a Class II medical device.
Frequently asked questions
What types of clinical microbiology laboratories can use the Colibrí System, and what is its primary purpose within those settings?
The Colibrí System is designed for clinical microbiology laboratories that perform antimicrobial susceptibility testing. Its primary purpose is to automate the detection of antimicrobial resistance in bacterial isolates, enabling rapid and precise identification of susceptibility profiles for clinical pathogens. This helps streamline workflows and improve turnaround times for critical diagnostic results.
Is the Colibrí System reusable, and if so, how are the consumables supplied and handled?
Yes, the Colibrí System itself is a reusable device. It is supplied with sterile consumables, which are intended for single-use to maintain sterility and accuracy in antimicrobial susceptibility testing. This design ensures that each test run begins with a clean and uncontaminated environment, reducing the risk of cross-contamination between samples.
What regulatory pathways has the Colibrí System followed, and what does this mean for its use in clinical settings?
The Colibrí System has undergone regulatory review through both the FDA’s 510(k) pathway, where it was determined to be substantially equivalent to a predicate device, and the In Vitro Diagnostic Regulation (IVDR) in Europe. This means it meets the necessary standards for antimicrobial susceptibility testing in the U.S. and EU markets, ensuring compliance with local regulatory requirements for clinical use.
How does the Colibrí System support efficiency in microbiology labs, particularly in terms of incubation time?
The Colibrí System is specifically designed to support short incubation protocols, which significantly reduces the time required for antimicrobial susceptibility testing compared to traditional manual methods. This acceleration in results helps microbiology labs respond more quickly to clinical needs, improving patient care and operational workflows.
What classification does the Colibrí System hold under regulatory standards, and what does this imply for its risk level?
The Colibrí System is classified as a Class II medical device under regulatory standards. This classification indicates it poses moderate risk, requiring compliance with additional controls to ensure its safety and performance. Class II devices undergo rigorous validation to balance effectiveness with risk mitigation, ensuring reliable antimicrobial susceptibility testing in clinical settings.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220546 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Copan Wasp Srl
Sources (2)
- FDA 510(k) K220546 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026