510(k) DEN070004
DEN070004 is an FDA 510(k) premarket notification submitted by Cepheid for the device "XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065". The FDA issued a decision of De Novo Granted on March 16, 2007. The device falls under product code OAI (Assay, Enterovirus Nucleic Acid), a Class II device regulated under 21 CFR 866.3225. Cepheid has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 16, 2007
- Date Received
- March 12, 2007
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Enterovirus Nucleic Acid
- Device Class
- Class II
- Regulation Number
- 866.3225
- Review Panel
- MI
- Submission Type
Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus.