DEN070004 is an FDA 510(k) submission for the XPERT EV, MODEL GXEV-100N-10. This device is classified as a Assay, Enterovirus Nucleic Acid (Class II - Special Controls, product code OAI).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Not Cleared (DENG) decision on March 16, 2007.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3225. 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..
| 510(k) Number | DEN070004 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 12, 2007 |
| Decision Date | March 16, 2007 |
| Days to Decision | 4 days |
| Submission Type | Post-NSE |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | OAI — Assay, Enterovirus Nucleic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3225 |
| Definition | 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. |