# K223245: Colibrí

- Pathway: 510(k) (Traditional)
- Applicant: Copan Wasp Srl
- Decided: Mar 20, 2023 after 151 days
- Product code: QQV (Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry)
- Device class: 2
- Regulation: 21 CFR 866.3378
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K032788 (2003). 7 ancestors in all.
1 later device descends 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)
- K220546: Colibrí System, Copan Wasp Srl (2022) Summary page 5.

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

## Indications for use
The Colibrí™ is an automated in vitro diagnostic specimen preparation system for use with WASPLab® to prepare MALDI-TOF targets for the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and microbial suspension for 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 Colibrí™ is an 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 Colibrí™ 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 Colibrí™ 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 Colibrí™ has not been validated for use in the identification or processing of yeast species, molds, Nocardia, or mycobacteria.

Source page: https://510kreport.com/device/K223245
Methodology: https://510kreport.com/methodology