510(k) DEN140019
DEN140019 is an FDA 510(k) premarket notification submitted by T2biosystems, Inc. for the device "T2CANDIDA AND T2DX INSTRUMENT". The FDA issued a decision of De Novo Granted on September 22, 2014. 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
- DENG (De Novo Granted)
- Decision Date
- September 22, 2014
- Date Received
- May 27, 2014
- Clearance Type
- Direct
- 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.