K221899 is an FDA 510(k) clearance for the The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml. This device is classified as a Susceptibility Test Plate, Antifungal (Class II - Special Controls, product code NGZ).
Submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on January 20, 2023, 204 days after receiving the submission on June 30, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640. The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format..
| 510(k) Number | K221899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2022 |
| Decision Date | January 20, 2023 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | NGZ — Susceptibility Test Plate, Antifungal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |
| Definition | The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format. |