510(k) · Cleared
ClearedColibri System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copan Wasp Srl · QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Cleared on Dec 27, 2021 as substantially equivalent to K181412 (bioMerieux, Inc., 2018) and 1 other predicate after a 775-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Dec 27, 2021
- Review
- 775 days
- Class
- Class II
- Product code
- QQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN170081 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QQV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QQV device
- #1 K223245 Colibríscore 9.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181412 | Vitek MSSummary page 5…510(K) SUMMARY III. LEGALLY MARKETED PREDICATE DEVICE Device Name VITEK MS 510(K) Number K181412 No reference Devices were used in this submission. IV. DEVICE DESCRIPTION The Copan Colibrí System is designed to be used as an… | 2018 |
| * | DEN170081 | MALDI Biotyper CA SystemSummary page 6…VITEK MS MALDI Biotyper CA System (K number) (K193138) (K181412) (DEN170081) Device Class II (special controls) Class II (special controls) Class II (special controls) Classificatio… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K181412.
How does its category compare?
All QQV devicesQQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QQV
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QQV
Too few QQV 510(k)s in any year since 2007 to give a median.
Recalls per year · QQV
No recall names QQV since 2007.
Adverse event reports per year · QQV
1in 2024
MAUDE reports naming product code QQV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (158 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193138: Colibri System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193138
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026