510(k) DEN140019
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.