K233184 is an FDA 510(k) clearance for the T2Bacteria® Panel. This device is classified as a Direct Blood Bacterial Nucleic Acid Detection System (Class II - Special Controls, product code QBX).
Submitted by T2biosystems, Inc. (Lexington, US). The FDA issued a Cleared decision on February 8, 2024, 133 days after receiving the submission on September 28, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3960. Amplification, Detection And Identification Of Microbial Pathogens Directly From Whole Blood Specimens.
| 510(k) Number | K233184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | February 08, 2024 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QBX - Direct Blood Bacterial Nucleic Acid Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3960 |
| Definition | Amplification, Detection And Identification Of Microbial Pathogens Directly From Whole Blood Specimens |