| Device |
assay, enterovirus nucleic acid |
| Regulation Description |
Enterovirus nucleic acid assay. |
| 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. |
| Physical State |
N/A |
| Technical Method |
Nucleic acid amplification assay system, self-contained cartridge with dedicated instrument. |
| Target Area |
Enterovirus (EV) RNA (enterovirus genome 5 prime untranslated region (UTR) between nucleotides 452 and 596) |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | OAI |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3225
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA
![[http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092757.htm]](../images/linker1.gif)
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|
| Third Party Review |
Not Third Party Eligible |
