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Colibri System

by Copan Wasp Srl

510(k) K193138

Active European Union and United States

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193138↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK193138 Date27 Dec 2021ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193138 decided 27 Dec 2021 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
QQV
Device class
Class II
Regulation
21 CFR Part 866.3378
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K193138

3 devices · FDA GUDID

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.

Devices cleared under K193138
UDI-DISize and differences
Colibrí™ Preparation Station W090
Copan Wasp Srl
W090 / W09058052870818435 —No longer on the market
Colibrí™ System W090.US
Copan Wasp Srl
W090.US / W090.US58052870816202 —No longer on the market
Colibrí™ Vision System W090-02
Copan Wasp Srl
W090-02 / W090-0258052870818428 —No longer on the market

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