OAI · Assay, Enterovirus Nucleic Acid
Microbiology · 21 CFR 866.3225 · Class 2
Overview
| Product Code | OAI |
|---|---|
| Device Name | Assay, Enterovirus Nucleic Acid |
| Regulation | 21 CFR 866.3225 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
An enterovirus nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of enterovirus ribonucleic acid (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.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA.” See § 866.1(e) for the availability of this guidance document.
Special Controls
The device is classified as Class II under regulation 21 CFR 866.3225 with special controls. The special control guidance document "Class II Special Control Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA" will shortly be available.
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA.” See § 866.1(e) for the availability of this guidance document.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063261 | NUCLISENS EASYQ ENTEROVIRUS SYSTEM | bioMerieux, Inc. | Jun 23, 2008 | SESE |
| DEN070004 | XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 | Cepheid | Mar 16, 2007 | DENG |
Top Applicants
- Cepheid — 1 clearance
- bioMerieux, Inc. — 1 clearance
