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U.S. Department of Health and Human Services

Product Classification

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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 CodeOAI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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] 
Third Party Review Not Third Party Eligible
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