OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay
Microbiology · 21 CFR 866.3980 · Class 2
Overview
| Product Code | OZE |
|---|---|
| Device Name | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Regulation | 21 CFR 866.3980 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B; (2) Influenza A subtype H1 and Influenza A subtype H3; (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B; (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapneumovirus; (6) Rhinovirus; and (7) Adenovirus.
Classification Rationale
Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;” (2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and (3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.
Special Controls
*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;” (2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and (3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | Centers for Disease Control and Prevention | Jul 11, 2025 | SESE |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | Centers for Disease Control and Prevention | Mar 14, 2025 | SESE |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) | Centers for Disease Control and Prevention | May 21, 2024 | SESE |
| K230236 | Lyra Influenza A+B Assay | Quidel Corporation | Mar 3, 2023 | SESE |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | Abbott Diagnostics Scarborough, Inc. | Jun 24, 2022 | SESE |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | Centers for Disease Control and Prevention | Mar 10, 2020 | SESE |
| K182513 | FluChip-8G Influenza A+B Assay | Indevr, Inc. | Apr 22, 2019 | SESE |
| K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit | Centers for Disease Control and Prevention | Mar 27, 2019 | SESE |
| K190204 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | Mar 18, 2019 | SESE |
| K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, | Centers For Disease Control and Prevention (CDC) | Jul 30, 2018 | SESE |
| K171641 | Accula Flu A/Flu B Test | Mesa Biotech, Inc. | Feb 6, 2018 | SESE |
| K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | Centers for Disease Control and Prevention | Aug 9, 2017 | SESE |
| K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit | Centers For Disease Control and Prevention (CDC) | Jun 30, 2016 | SESE |
| K153148 | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping | Centers For Disease Control and Prevention (CDC) | Dec 1, 2015 | SESE |
| K141859 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING | Centers for Disease Control and Prevention | Aug 1, 2014 | SESE |
| K140857 | INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Centers for Disease Control and Prevention | Apr 25, 2014 | SESE |
| K133869 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT | Center For Disease Control and Prevention (Cdc) | Jan 17, 2014 | SESE |
| K132508 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Centers for Disease Control and Prevention | Sep 23, 2013 | SESE |
| K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Quidel Corp. | Aug 29, 2013 | SESE |
| K113777 | QUIDEL MOLECULAR INFLUENZA A+B | Quidel Corp. | Mar 15, 2012 | SESE |
Top Applicants
- Centers for Disease Control and Prevention — 9 clearances
- Centers For Disease Control and Prevention (CDC) — 3 clearances
- Quidel Corp. — 2 clearances
- Abbott Diagnostics Scarborough, Inc. — 1 clearance
- Alere Scarborough, Inc. — 1 clearance
