# K193138: Colibri System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Wasp Srl
- Decided: Dec 27, 2021 after 775 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: 2 generations back to DEN170081 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181412: Vitek MS, bioMerieux, Inc. (2018) Summary page 5.
- DEN170081: MALDI Biotyper CA System, Bruker Daltonik GmbH (2018) Summary page 6.

## 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 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/lonization-Time Of Flight Mass Spectrometry) target slides. 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 analyzer. 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 identification of yeast species.

Source page: https://510kreport.com/device/K193138
Methodology: https://510kreport.com/methodology