K192665 is an FDA 510(k) clearance for the Accelerate Pheno System, Accelerate PhenoTest BC Kit. This device is classified as a Positive Blood Culture Identification And Ast Kit (Class II - Special Controls, product code PRH).
Submitted by Accelerate Diagnostics, Inc. (Tucson, US). The FDA issued a Cleared decision on September 15, 2020, 356 days after receiving the submission on September 25, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1650. Fluorescence In Situ Hybridization (fish) Identification And Quantitative, Antimicrobial Susceptibility Testing (ast) Kit Intended For Simultaneous Detection And Identification Of Multiple Microbial Targets..
| 510(k) Number | K192665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2019 |
| Decision Date | September 15, 2020 |
| Days to Decision | 356 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PRH - Positive Blood Culture Identification And Ast Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1650 |
| Definition | Fluorescence In Situ Hybridization (fish) Identification And Quantitative, Antimicrobial Susceptibility Testing (ast) Kit Intended For Simultaneous Detection And Identification Of Multiple Microbial Targets. |