Identifiers
- 510(k) Number
- K212727 FDA 510(k)
- FDA Product Code
- QDP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3985 FDA 510(k)
- Regulation Number
- 866.3985 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FilmArray Pneumonia Panel is a multiplex molecular diagnostic test designed for the identification of pathogens associated with lower respiratory tract infections. It detects 33 clinically relevant targets from sputum and bronchoalveolar lavage specimens to assist in the identification of pathogens responsible for pneumonia symptoms.
This diagnostic test provides results in approximately one hour and has received FDA 510K clearance. It is classified as a Class 2 device under regulation number 866.3985 for use in microbiology settings.
Frequently asked questions
What is the FilmArray Pneumonia Panel used for?
This multiplex molecular diagnostic test is designed to identify 33 clinically relevant pathogens associated with lower respiratory tract infections. It is used to assist clinicians in determining the specific pathogens responsible for a patient's pneumonia symptoms.
What types of specimens are required for this test?
The panel is designed to process sputum and bronchoalveolar lavage specimens. These sample types are used to detect the presence of the 33 targeted pathogens identified by the molecular assay.
How long does it take to receive results from the FilmArray Pneumonia Panel?
The diagnostic test is designed for efficiency in microbiology settings, providing results in approximately one hour from the time of testing.
What is the regulatory status of this device?
The FilmArray Pneumonia Panel has received FDA 510K clearance. It is classified as a Class 2 device under regulation number 866.3985 for use in microbiology settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: The BioFire® FilmArray® Pneumonia Panel | BioFire Diagnostics, BIOFIRE® FILMARRAY® Pneumonia (PN) Panel | Pioneering Diagnostics, BIOFIRE FILMARRAY Pneumonia (PN) Panel
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212727 | Class II | Active |
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Manufacturer
- Manufacturer
- BioFire Diagnostics, LLC
Sources (1)
- FDA 510(k) K212727 24 fields · synced Sep 23, 2026