OCCClass II

Respiratory Virus Panel Nucleic Acid Assay System

21 CFR 866.3980 / Microbiology

OCC is the FDA product code for Respiratory Virus Panel Nucleic Acid Assay System, a class II device type, regulated under 21 CFR 866.3980. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 79 510(k) clearances under this code, the most recent dated 2026-05-01, and 25 recalls.

Classification record

Product code: OCC
Device name: Respiratory Virus Panel Nucleic Acid Assay System
FDA definition: 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: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.
Regulation: 21 CFR 866.3980
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 80
Ingested recalls: 25

Clearances, product code OCC

By decision year

80 clearances under product code OCC with a decision year between 2008 and 2026, 2017 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code OCC by decision year
Year	Clearances
2008	4
2009	6
2010	2
2011	9
2012	6
2013	6
2014	4
2015	8
2016	7
2017	10
2018	4
2019	5
2020	2
2021	1
2022	1
2023	2
2024	1
2026	2

Applicants with the most clearances

Product code OCC

Applicants holding the most 510(k) clearances under product code OCC
Applicant	Clearances
Luminex Molecular Diagnostics Inc	9
Cepheid	8
Luminex Corporation	7
Alere Scarborough, Inc.	5
BioFire Diagnostics, LLC	5
DiaSorin Molecular LLC	5
Ortho-Clinical Diagnostics, Inc.	5
Gen-Probe Prodesse, Inc.	4
Hologic, Inc.	4
Roche Molecular Systems Inc	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order