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 Luminex Molecular Diagnostics, Inc., Cepheid and Nanosphere, Inc..

80
Total
79
Cleared
99d
Avg days
2008
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 155d recently vs 97d historically

FDA 510(k) Cleared Respiratory Virus Panel Nucleic Acid Assay System Devices (Product Code OCC)

80 devices
1–24 of 80
Cleared Oct 21, 2026
DASH Flu A/B Test
K261347
Nuclein, LLC
Microbiology · 180d
Cleared May 01, 2026
BioCode® Respiratory Pathogen Panel (RPP)
K254139
Applied BioCode, Inc.
Microbiology · 130d
Cleared Oct 02, 2024
NxTAG® Respiratory Pathogen Panel
K242613
Luminex Molecular Diagnostics, Inc.
Microbiology · 29d
Cleared Oct 10, 2023
ID NOW Influenza A & B 2
K232775
Abbott Diagnostics Scarborough, 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
Cleared Aug 22, 2020
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
K201505
Diasorin Molecular, LLC
Microbiology · 78d
Cleared Feb 10, 2020
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
K200065
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared Dec 23, 2019
BioCode Respiratory Pathogen Panel (RPP)
K192485
Applied BioCode, Inc.
Microbiology · 104d
Cleared Dec 11, 2019
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
K193167
Luminex Molecular Diagnostics, Inc.
Microbiology · 26d
Cleared Jul 24, 2019
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
K191729
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Jul 11, 2019
ID NOW Influenza A & B 2
K191534
Abbott Diagnostics Scarborough, Inc.
Microbiology · 31d
Cleared May 18, 2019
QIAstat-Dx Respiratory Panel
K183597
QIAGEN GmbH
Microbiology · 148d
Cleared Nov 23, 2018
Accula RSV Test
K181443
Mesa Biotech, Inc.
Microbiology · 176d
Cleared Aug 15, 2018
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
K181289
Cepheid
Microbiology · 91d
Cleared Jul 24, 2018
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
K180218
Cepheid
Microbiology · 180d
Cleared Jan 26, 2018
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
K173932
Alere Scarborough, Inc.
Microbiology · 31d
Cleared Dec 19, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
K171552
Cepheid
Microbiology · 207d
Cleared Dec 04, 2017
Panther Fusion AdV/hMPV/RV Assay
K172629
Hologic, Inc.
Microbiology · 94d
Cleared Oct 16, 2017
Solana RSV+hMPV Assay
K171974
Quidel Corporation
Microbiology · 108d
Cleared Sep 29, 2017
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
K171792
Alere Scarborough, Inc.
Microbiology · 105d
Cleared Sep 26, 2017
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
K171963
Hologic, Inc.
Microbiology · 88d
Cleared Aug 30, 2017
Idylla Respiratory (IFV-RSV) Panel
K163628
Janssen Pharmaceutica NV
Microbiology · 251d

About Product Code OCC - Regulatory Context

510(k) Submission Activity

80 total 510(k) submissions under product code OCC since 2008, with 79 receiving FDA clearance (average review time: 99 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - OCC Product Code

Recent submissions under OCC have taken an average of 155 days to reach a decision - up from 97 days historically. Manufacturers should account for longer review timelines in current project planning.

OCC devices are reviewed by the Microbiology panel. Browse all Microbiology devices →