FilmArray Respiratory Panel 2 (RP2)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170604 FDA 510(k)
- FDA Product Code
- OCC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3980 FDA 510(k)
- Regulation Number
- 866.3980 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FilmArray Respiratory Panel 2 (RP2) is a Respiratory Virus Panel Nucleic Acid Assay System, designed for the simultaneous detection and identification of multiple respiratory pathogens. As a molecular diagnostic tool, it employs nucleic acid amplification technology to detect viral RNA from clinical specimens, enabling rapid and comprehensive pathogen profiling for respiratory infections.
This in vitro diagnostic device is intended for use in clinical microbiology laboratories and is supplied as a single-use cartridge. The RP2 is cleared by the FDA under a 510(k) submission (K170604) and classified as a Class II device (regulation number 866.3980). It operates on the FilmArray 2.0 or FilmArray Torch Systems, delivering results within approximately 45 minutes. Sterility and single-use compliance ensure patient safety and regulatory adherence.
Frequently asked questions
What is the FilmArray Respiratory Panel 2 (RP2) used for?
The FilmArray RP2 is a molecular diagnostic tool designed to simultaneously detect and identify multiple respiratory pathogens from clinical specimens. It uses nucleic acid amplification technology to identify viral RNA, enabling rapid and comprehensive pathogen profiling for respiratory infections. This helps clinicians make faster, more accurate diagnoses for conditions like flu, RSV, and other respiratory illnesses.
How is the FilmArray RP2 supplied and is it single-use?
The FilmArray RP2 is supplied as a single-use cartridge, ensuring sterility and patient safety. Each cartridge is intended for one-time use only, which aligns with regulatory requirements for in vitro diagnostics and minimizes the risk of cross-contamination or infection.
Which systems can the FilmArray RP2 be used with?
The FilmArray RP2 is compatible with the FilmArray 2.0 and FilmArray Torch Systems. These platforms process the cartridge and deliver results within approximately 45 minutes, making it a highly efficient tool for clinical microbiology laboratories.
Is the FilmArray RP2 sterile and how should it be stored?
Yes, the FilmArray RP2 is sterile and designed for single-use. It should be stored according to the manufacturer’s instructions, typically in a cool, dry place away from direct sunlight. Proper storage ensures the cartridge remains effective and maintains its sterility until use.
What regulatory pathway does the FilmArray RP2 follow?
The FilmArray RP2 is cleared by the FDA under a 510(k) submission (K170604) and classified as a Class II device under regulation number 866.3980. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness.
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: Respiratory Pathogen Panel Test | BioFire Diagnostics, BIOFIRE® Respiratory 2.1 (RP 2.1) Panel | Pioneering Diagnostics, BIOFIRE® Respiratory 2.1 (RP2.1) Panel & Respiratory 2.1 plus (RP2 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170604 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioFire Diagnostics, LLC
Sources (1)
- FDA 510(k) K170604 24 fields · synced Oct 1, 2026