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Aries System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151917

by Luminex Corporation

Identifiers

510(k) Number
K151917 FDA 510(k)
FDA Product Code
OOI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.2570 FDA 510(k)
Regulation Number
862.2570 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Aries System is a Real-Time Nucleic Acid Amplification System, designed for automated nucleic acid extraction, amplification, and detection. It performs real-time PCR assays to identify and quantify nucleic acid targets from diverse sample types, supporting clinical chemistry applications. This integrated platform streamlines workflows by combining sample preparation, amplification, and detection into a single process.

The device is intended for use in clinical laboratory settings and has received FDA 510(k) clearance under the Traditional pathway. It is classified as a Class II medical device (regulation number 862.2570) and is supplied as a reusable instrument. The system operates in non-sterile environments and requires proper calibration and maintenance as outlined in its operational manuals. No specific MRI safety information is provided, and its use is governed by regulatory submissions filed under the product code OOI.

Frequently asked questions

What types of clinical samples can the Aries System process, and how does it streamline workflows in a lab setting?

The Aries System is designed for automated nucleic acid extraction, amplification, and detection using real-time PCR assays. It supports diverse sample types relevant to clinical chemistry applications, integrating sample preparation, amplification, and detection into a single automated workflow. This eliminates the need for separate manual steps, reducing hands-on time and potential for human error while accelerating results.

Is the Aries System intended for single-use or reusable applications, and what maintenance is required?

The Aries System is supplied as a reusable instrument, meaning it is built for repeated use in clinical laboratory settings. Like all reusable devices, it requires proper calibration, routine maintenance, and adherence to the operational manuals provided by Luminex Corporation to ensure accuracy, reliability, and compliance with regulatory standards.

How is the sterility of the Aries System handled, and what considerations should labs have when using it?

The Aries System operates in non-sterile environments, meaning it is not designed for sterile procedures or direct patient contact. Laboratories must follow standard infection control protocols when handling samples and maintaining the device to prevent contamination. Sterility is not a feature of the instrument itself but must be managed through proper workflow practices.

What regulatory pathway was followed for the Aries System’s FDA clearance, and how does this affect its use?

The Aries System received FDA clearance under the Traditional 510(k) pathway, determined to be *substantially equivalent* to a predicate device. This means it was evaluated by the FDA’s Clinical Chemistry (CH) Advisory Committee and classified as a Class II medical device (regulation number 862.2570). Its use is governed by the regulatory submissions filed under product code OOI, ensuring compliance with FDA requirements for real-time nucleic acid amplification systems in clinical chemistry.

Are there any specific storage requirements or environmental conditions that must be met for the Aries System?

While the provided data does not specify exact storage conditions, as a reusable instrument, the Aries System should be stored in a clean, controlled environment to prevent contamination and ensure proper functionality. Laboratories should refer to Luminex Corporation’s operational manuals for detailed guidelines on maintenance, calibration, and environmental considerations to optimize performance and longevity.

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: PDF ARIES® M1 System, PDF ARIES® System, Aries Systems Corporation, Luminex Aries M12V1 Automated Sample-To-Answer PCR Instrument System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Luminex Corporation

Sources (1)

  • FDA 510(k) K151917 24 fields · synced Oct 6, 2026