21 CFR 866.3225 — Assay, Enterovirus Nucleic Acid
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3225
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OAI | Assay, Enterovirus Nucleic Acid | 2 | 2 |
Special Controls
OAI — Assay, Enterovirus Nucleic Acid
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.
De Novo Order DEN070004
OAI — Assay, Enterovirus Nucleic Acid
*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.
eCFR
OAI — Assay, Enterovirus Nucleic Acid
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.
Ecfr Llm
