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
Cleared
Aug 31, 2023
BD Kiestra IdentifA
Becton, Dickinson and Company
Microbiology
372d
Cleared
Mar 20, 2023
Colibrí
Copan Wasp Srl
Microbiology
151d
Cleared
Dec 27, 2021
Colibri System
Copan Wasp Srl
Microbiology
775d
Cleared
Nov 03, 2021
BD Kiestra IdentifA
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.