K191964 is an FDA 510(k) clearance for the BD Kiestra IdentifA. This device is classified as a Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry (Class II - Special Controls, product code QQV).
Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on November 3, 2021, 834 days after receiving the submission on July 23, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3378. 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) Number | K191964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2019 |
| Decision Date | November 03, 2021 |
| Days to Decision | 834 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QQV — Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3378 |
| 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). |