K231336 is an FDA 510(k) clearance for the T2 Biothreat Panel. This device is classified as a Multiplex Nucleic Acid Detection System For Biothreat Agents (Class II - Special Controls, product code QVR).
Submitted by T2biosystems, Inc. (Lexington, US). The FDA issued a Cleared decision on September 15, 2023, 130 days after receiving the submission on May 8, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.4000. A Multiplex Nucleic Acid Detection System For Biothreat Agents Is A Qualitative In Vitro Diagnostic Test For Detection And Identification Of Nucleic Acids From Biothreat Pathogens In Human Clinical Specimens.
| 510(k) Number | K231336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2023 |
| Decision Date | September 15, 2023 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QVR - Multiplex Nucleic Acid Detection System For Biothreat Agents |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.4000 |
| Definition | A Multiplex Nucleic Acid Detection System For Biothreat Agents Is A Qualitative In Vitro Diagnostic Test For Detection And Identification Of Nucleic Acids From Biothreat Pathogens In Human Clinical Specimens |