K240854 is an FDA 510(k) clearance for the Accelerate Arc System. This device is classified as a Mass Spectrometry, Microorganism Identification, Blood Culture (Class II - Special Controls, product code QNJ).
Submitted by Accelerate Diagnostics, Inc. (Tucson, US). The FDA issued a Cleared decision on September 26, 2024, 182 days after receiving the submission on March 28, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3378. Blood Culture Processing Device That Includes Associated Reagents That Are Intended To Concentrate And Purify Microbial Cells From Blood Culture Samples Identified As Positive By A Continuous Monitoring Blood Culture System With Organisms Subsequently Identified By Spectrometry..
| 510(k) Number | K240854 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2024 |
| Decision Date | September 26, 2024 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QNJ - Mass Spectrometry, Microorganism Identification, Blood Culture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3378 |
| Definition | Blood Culture Processing Device That Includes Associated Reagents That Are Intended To Concentrate And Purify Microbial Cells From Blood Culture Samples Identified As Positive By A Continuous Monitoring Blood Culture System With Organisms Subsequently Identified By Spectrometry. |