K193419 is an FDA 510(k) clearance for the MBT Sepsityper. This device is classified as a Mass Spectrometry, Microorganism Identification, Blood Culture (Class II - Special Controls, product code QNJ).
Submitted by Bruker Daltonik GmbH (Bremen, DE). The FDA issued a Cleared decision on December 27, 2020, 384 days after receiving the submission on December 9, 2019.
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 | K193419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2019 |
| Decision Date | December 27, 2020 |
| Days to Decision | 384 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| 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. |