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Aries Flu A/B & RSV Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161220

by Luminex Corporation

Identifiers

510(k) Number
K161220 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 Aries Flu A/B & RSV Assay is a Respiratory Virus Panel Nucleic Acid Assay System, designed for the qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in clinical specimens. It employs real-time polymerase chain reaction (PCR) technology to provide rapid and accurate identification of these respiratory pathogens in nasopharyngeal swabs (NPS).

This in vitro diagnostic device is intended for use in clinical microbiology laboratories to aid in the diagnosis of respiratory tract infections. Supplied as a single-use assay, it requires no additional preparation beyond standard specimen handling and does not require MRI safety considerations. The device is authorized under FDA 510(k) clearance (K161220) and falls under Class II regulatory classification (866.3980). Storage and handling follow standard molecular diagnostic protocols.

Frequently asked questions

What types of clinical specimens can the ARIES® Flu A/B & RSV Assay detect, and how is it typically used in a lab setting?

The ARIES® Flu A/B & RSV Assay is designed specifically for nasopharyngeal swabs (NPS) to detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid. It employs real-time PCR technology for rapid and accurate identification of these pathogens, making it useful in clinical microbiology labs to aid in diagnosing respiratory tract infections. No additional specimen preparation beyond standard handling is required.

Is the ARIES® Flu A/B & RSV Assay intended for single-use or repeated use, and how should it be stored?

The ARIES® Flu A/B & RSV Assay is supplied as a single-use device, meaning each assay kit is intended for one test run. Storage and handling follow standard molecular diagnostic protocols, which typically involve maintaining the device in a controlled environment to preserve its integrity until use.

What regulatory pathway was followed for the ARIES® Flu A/B & RSV Assay, and what does this mean for its use in clinical settings?

The ARIES® Flu A/B & RSV Assay was authorized through the FDA’s 510(k) clearance process, specifically under the Traditional pathway, and is classified as a Class II device. This means it has been determined to be substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. Clinicians can rely on its regulatory clearance as evidence of its intended use for qualitative detection of Flu A/B and RSV in nasopharyngeal swabs.

Are there any special considerations for handling or safety when using the ARIES® Flu A/B & RSV Assay, such as MRI compatibility or environmental requirements?

The ARIES® Flu A/B & RSV Assay does not require MRI safety considerations, as it is not a device that would be exposed to MRI environments. Standard molecular diagnostic protocols should be followed for storage and handling, ensuring proper containment and disposal of clinical specimens. No additional safety precautions beyond typical lab practices are mentioned in the device description.

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: Multicenter Clinical Evaluation of the Luminex Aries Flu A/B & RSV ..., LUMINEX CORPORATION 50-10020 ARIES® Flu A/B & RSV Assay, ARIES Flu A/B & RSV Assay - BioCosm

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Luminex Corporation

Sources (1)

  • FDA 510(k) K161220 24 fields · synced Oct 6, 2026