Colibrí System
510(k) K220546
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK220546 | Date5 Oct 2022 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K220546 decided 5 Oct 2022 Active
- EUDAMED Active
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- LON
- Device class
- Class II
- Regulation
- 21 CFR Part 866.1645
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
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.
Devices cleared under K220546
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Colibrí™ System W090.US | W090.US / W090.US | 58052870816202 | — | No longer on the market |
| Colibrí™ Vision System W090-02 | W090-02 / W090-02 | 58052870818428 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation).
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