DeviceClearance

Product code OCC— Microbiology

FILMARRAY RESPIRATORY PANEL (RP)

Classification name
Respiratory Virus Panel Nucleic Acid Assay System
Device class
Class 2
Regulation
21 CFR 866.3980
Advisory panel
Microbiology
Total cleared
79
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OCC under 21 CFR 866.3980, via openFDA

Market context for product code OCC

FDA has cleared 79 devices under product code OCC between 2008 and 2026, filed by 30 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OCC

Adverse events under product code OCC

product code OCC
Death
3
Malfunction
706
Total
709

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OCC

Data sourced from openFDA. This site is unofficial and independent of the FDA.