QQV · Class II · 21 CFR 866.3378

FDA Product Code QQV: Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

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).

Leading manufacturers include Becton, Dickinson and Company and Copan Wasp Srl.

4
Total
4
Cleared
533d
Avg days
2021
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry Devices (Product Code QQV)

4 devices
1–4 of 4
Cleared Aug 31, 2023
BD Kiestra IdentifA
K222563
Becton, Dickinson and Company
Microbiology · 372d
Cleared Mar 20, 2023
Colibrí
K223245
Copan Wasp Srl
Microbiology · 151d
Cleared Dec 27, 2021
Colibri System
K193138
Copan Wasp Srl
Microbiology · 775d
Cleared Nov 03, 2021
BD Kiestra IdentifA
K191964
Becton, Dickinson and Company
Microbiology · 834d

About Product Code QQV - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code QQV since 2021, with 4 receiving FDA clearance (average review time: 533 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

QQV devices are reviewed by the Microbiology panel. Browse all Microbiology devices →