510(k) K222563
K222563 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Kiestra IdentifA". The FDA issued a decision of Substantially Equivalent on August 31, 2023. The device falls under product code QQV (Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry), a Class II device regulated under 21 CFR 866.3378. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2023
- Date Received
- August 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
- Device Class
- Class II
- Regulation Number
- 866.3378
- Review Panel
- MI
- Submission Type
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).