K234063 is an FDA 510(k) clearance for the T2Candida 1.1 Panel. This device is classified as a Candida Species Nucleic Acid Detection System (Class II - Special Controls, product code PII).
Submitted by T2biosystems, Inc. (Lexington, US). The FDA issued a Cleared decision on September 13, 2024, 266 days after receiving the submission on December 22, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3960. The Candida Species Nucleic Acid Detection System Is A Qualitative Panel For The Direct Detection Of Candida Species In Whole Blood Specimens From Patients With Symptoms Of, Or Medical Conditions Predisposing The Patients To, Invasive Fungal Infections. The Test Is Indicated For The Presumptive Diagnosis Of Candidemia. The Test Is Performed Independent Of Blood Culture. Concomitant Blood Cultures Are Necessary To Recover Organisms For Susceptibility Testing Or Further Identification..
| 510(k) Number | K234063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2023 |
| Decision Date | September 13, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PII - Candida Species Nucleic Acid Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3960 |
| Definition | The Candida Species Nucleic Acid Detection System Is A Qualitative Panel For The Direct Detection Of Candida Species In Whole Blood Specimens From Patients With Symptoms Of, Or Medical Conditions Predisposing The Patients To, Invasive Fungal Infections. The Test Is Indicated For The Presumptive Diagnosis Of Candidemia. The Test Is Performed Independent Of Blood Culture. Concomitant Blood Cultures Are Necessary To Recover Organisms For Susceptibility Testing Or Further Identification. |