OCC · Respiratory Virus Panel Nucleic Acid Assay System
Microbiology · 21 CFR 866.3980 · Class 2
Overview
| Product Code | OCC |
|---|---|
| Device Name | Respiratory Virus Panel Nucleic Acid Assay System |
| 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 78)
Showing 20 most recent of 78 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen Panel | Luminex Molecular Diagnostics, Inc. | Oct 2, 2024 | SESE |
| K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | Oct 10, 2023 | SESE |
| K231017 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | May 5, 2023 | SESE |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | Jul 6, 2022 | SESE |
| K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | Feb 16, 2021 | SESE |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | Diasorin Molecular, LLC | Aug 22, 2020 | SESE |
| K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | Feb 10, 2020 | SESE |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | Dec 23, 2019 | SESE |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Luminex Molecular Diagnostics, Inc. | Dec 11, 2019 | SESE |
| K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | Roche Molecular Systems, Inc. | Jul 24, 2019 | SESE |
| K191534 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | Jul 11, 2019 | SESE |
| K183597 | QIAstat-Dx Respiratory Panel | QIAGEN GmbH | May 18, 2019 | SESE |
| K181443 | Accula RSV Test | Mesa Biotech, Inc. | Nov 23, 2018 | SESE |
| K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System | Cepheid | Aug 15, 2018 | SESE |
| K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | Cepheid | Jul 24, 2018 | SESE |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Alere Scarborough, Inc. | Jan 26, 2018 | SESE |
| K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | Cepheid | Dec 19, 2017 | SESE |
| K172629 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | Dec 4, 2017 | SESE |
| K171974 | Solana RSV+hMPV Assay | Quidel Corporation | Oct 16, 2017 | SESE |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | Sep 29, 2017 | SESE |
Top Applicants
- Luminex Molecular Diagnostics, Inc. — 9 clearances
- Cepheid — 8 clearances
- Nanosphere, Inc. — 6 clearances
- Alere Scarborough, Inc. — 5 clearances
- Biofire Diagnostics, LLC — 4 clearances
