OZB · Dengue Nucleic Acid Amplification Assay (Naat)

Microbiology · 21 CFR 866.3946 · Class 2

Overview

Identification

Dengue virus nucleic acid amplification test reagents are devices that consist of primers, probes, enzymes, and controls for the amplification and detection of dengue virus serotypes 1, 2, 3, or 4 from viral ribonucleic acid (RNA) in human serum and plasma from individuals who have signs and symptoms consistent with dengue (mild or severe). The identification of dengue virus serotypes 1, 2, 3, or 4 in human serum and plasma (sodium citrate) collected from human patients with dengue provides epidemiologic information for surveillance of circulating dengue viruses.

Classification Rationale

Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents.” For availability of the guideline document, see § 866.1(e).

Special Controls

The device is classified as Class II under regulation 21 CFR 866.3946 with special controls. The special controls guidance document "Class II Special Controls Guidance Document: Dengue virus Nucleic Acid Amplification Test Reagents" will shortly be available.

*Classification.* Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents.” For availability of the guideline document, see § 866.1(e).

Recent Cleared Devices (1 of 1)

Top Applicants

• Centers for Disease Control and Prevention — 1 clearance