Product Classification

• Device: dengue nucleic acid amplification assay (naat)
• Regulation Description: Dengue virus nucleic acid amplification test reagents.
• Definition: A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).
• Physical State: Dengue nucleic acid amplification and detection reagents including primers and probes, positive controls, and human specimen extraction control
• Technical Method: Uses nucleic acid amplification technology for detection of dengue virus target sequences
• Target Area: Human clinical samples e.g., blood serum, plasma
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: OZB
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3946
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Class II Special Controls Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents - Guideline for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible