# K220546: Colibrí System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Wasp Srl
- Decided: Oct 5, 2022 after 222 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K032788 (2003). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103752: Vitek 2 Systems (PC) 5.02 Software, bioMerieux, Inc. (2011) Summary page 5.

## Most influential descendants
- K223245: Colibrí (2023), 1 descendant of its own
- K232756: Colibrí (2023), 0 descendants of its own

## Indications for use
The Colibri™ System is an in vitro diagnostic device comprised of the Colibri™ Vision System and Colibri™ Preparation Station for use with the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and with the bioMérieux VITEK® 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media. The Colibri™ System is a semi-automated pre-analytical processor that picks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry) target slides for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment. The Colibri™ software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers. Bacterial suspensions for AST and purity plates are identified by barcode label. The Colibri™ System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bacterial infections. The Colibri™ System has not been validated for use in the identification or processing of yeast species, molds, Nocardia, or mycobacteria.

Source page: https://510kreport.com/device/K220546
Methodology: https://510kreport.com/methodology