FDA product code QQV: Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
QQV is the FDA product code for automated system for sample preparation and identification of microorganisms from cultured isolates by mass spectrometry. It is a Class II device, regulated under 21 CFR 866.3378 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under QQV, 2 in the last five years, from 2 different applicants. The average 510(k) review took 533 days (median 574).
Definition
An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).
Classification
| Field | Value |
|---|---|
| Device name | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry |
| Device class | Class II |
| Regulation | 21 CFR 866.3378 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QQV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 2 | 804 |
| 2023 | 2 | 262 |
Compare with all 510(k) review times · Search every QQV clearance
Top QQV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson and Company | 2 | 2023-08-31 |
| Copan Wasp Srl | 2 | 2023-03-20 |
Most recent QQV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222563 | Becton, Dickinson and Company | BD Kiestra IdentifA | 2023-08-31 | 372 |
| K223245 | Copan Wasp Srl | Colibrí | 2023-03-20 | 151 |
| K193138 | Copan Wasp Srl | Colibri System | 2021-12-27 | 775 |
| K191964 | Becton, Dickinson and Company | BD Kiestra IdentifA | 2021-11-03 | 834 |
Recalls for QQV devices
openFDA lists no recalls for product code QQV.
Frequently asked questions
What is FDA product code QQV?
QQV is the FDA product code for automated system for sample preparation and identification of microorganisms from cultured isolates by mass spectrometry. It is a Class II device, regulated under 21 CFR 866.3378 and reviewed by the Microbiology panel.
What device class is QQV?
Class II, regulation 21 CFR 866.3378. Typical premarket route: 510(k).
How long does a 510(k) take for product code QQV?
Across 4 cleared submissions the average was 533 days from receipt to decision (median 574).
Which companies have the most QQV clearances?
Becton, Dickinson and Company (2); Copan Wasp Srl (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QQV
- Run a recall and safety report across every QQV manufacturer
- Watch product code QQV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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