Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
The Automated System for Sample Preparation and Identification of Microorganisms from Cultured Isolates by Mass Spectrometry is an automated in vitro diagnostic system that prepares 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). This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.3378 in the Microbiology specialty. It carries product code QQV and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QQV
- Device Class
- FDA class 2
- Regulation Number
- 866.3378
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222563 | BD Kiestra IdentifA | Aug 31, 2023 | Substantially Equivalent | Becton, Dickinson and Company |
| K223245 | Colibrí | Mar 20, 2023 | Substantially Equivalent | Copan Wasp Srl |
| K193138 | Colibri System | Dec 27, 2021 | Substantially Equivalent | Copan Wasp Srl |
| K191964 | BD Kiestra IdentifA | Nov 03, 2021 | Substantially Equivalent | Becton, Dickinson and Company |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.