OCC · Class II · 21 CFR 866.3980

FDA Product Code OCC: Respiratory Virus Panel Nucleic Acid Assay System

Under FDA product code OCC, respiratory virus panel nucleic acid assay systems are cleared for multiplex detection of respiratory viral pathogens.

These assays simultaneously identify multiple common respiratory viruses — including influenza A/B, RSV, parainfluenza, adenovirus, and human metapneumovirus — from a single respiratory specimen, enabling rapid and comprehensive viral diagnosis for patient cohorting and treatment decisions.

OCC devices are Class II medical devices, regulated under 21 CFR 866.3980 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Roche Molecular Systems, Inc., Hologic, Inc. and Luminex Molecular Diagnostics, Inc..

4
Total
4
Cleared
71d
Avg days
2021
Since

List of Respiratory Virus Panel Nucleic Acid Assay System devices cleared through 510(k)

4 devices
1–4 of 4
Cleared Oct 02, 2024
NxTAG® Respiratory Pathogen Panel
K242613
Luminex Molecular Diagnostics, Inc.
Microbiology · 29d
Cleared May 05, 2023
Panther Fusion AdV/hMPV/RV Assay
K231017
Hologic, Inc.
Microbiology · 25d
Cleared Jul 06, 2022
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
K213822
Roche Molecular Systems, Inc.
Microbiology · 210d
Cleared Feb 16, 2021
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
K210234
Roche Molecular Systems, Inc.
Microbiology · 19d

How to use this database

This page lists all FDA 510(k) submissions for Respiratory Virus Panel Nucleic Acid Assay System devices (product code OCC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →