510(k) K234063
K234063 is an FDA 510(k) premarket notification submitted by T2biosystems, Inc. for the device "T2Candida 1.1 Panel". The FDA issued a decision of Substantially Equivalent on September 13, 2024. The device falls under product code PII (Candida Species Nucleic Acid Detection System), a Class II device regulated under 21 CFR 866.3960. T2biosystems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2024
- Date Received
- December 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Candida Species Nucleic Acid Detection System
- Device Class
- Class II
- Regulation Number
- 866.3960
- Review Panel
- MI
- Submission Type
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.