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ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172402

by Luminex Corporation

Identifiers

510(k) Number
K172402 FDA 510(k)
FDA Product Code
PGX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.2680 FDA 510(k)
Regulation Number
866.2680 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ARIES Group A Strep Assay is a real-time polymerase chain reaction (PCR) based in vitro diagnostic device for the qualitative detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus) in throat swab specimens. It functions as a nucleic acid amplification system, enabling rapid identification of the pathogen in patients presenting with pharyngitis symptoms.

This device is supplied as a single-use cassette containing nucleic acid purification reagents, an internal sample process control, and lyophilized PCR master mix. It is intended for use in clinical microbiology laboratories and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (PGX). The assay is designed for automated processing with minimal hands-on time, delivering results within approximately two hours.

Frequently asked questions

What is the ARIES Group A Strep Assay designed to detect, and how does it work?

The ARIES Group A Strep Assay is designed to detect *Streptococcus pyogenes* (Group A β-hemolytic Streptococcus) in throat swab specimens. It uses real-time polymerase chain reaction (PCR) technology, which amplifies and detects the pathogen’s genetic material to confirm its presence. This method provides rapid, accurate identification of the bacteria responsible for pharyngitis symptoms, typically delivering results within about two hours.

Is the ARIES Group A Strep Assay intended for single-use or repeated use, and how is it supplied?

The ARIES Group A Strep Assay is supplied as a single-use cassette containing all necessary reagents, including nucleic acid purification components, an internal sample process control, and a lyophilized PCR master mix. This design ensures each test is performed with fresh, uncontaminated materials, eliminating the need for reuse.

What type of laboratory setting is this assay intended for, and what are its key operational advantages?

This assay is specifically designed for use in clinical microbiology laboratories, where trained personnel can operate automated systems. Its key advantages include minimal hands-on time due to automated processing and rapid turnaround—results are typically available within approximately two hours, streamlining workflow for pharyngitis evaluations.

How should the ARIES Group A Strep Assay be stored, and are there any special handling requirements?

While the exact storage conditions aren’t detailed in the provided data, the assay is supplied as a single-use cassette with lyophilized components, which generally requires refrigeration (typically 2–8°C) to maintain stability. Always follow the manufacturer’s instructions for unpacking and handling to preserve sterility and performance, as improper storage could compromise test validity.

What regulatory pathway was used for FDA clearance of this device, and what classification does it hold?

The ARIES Group A Strep Assay received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (PGX). This classification reflects its role as a moderate-risk diagnostic device, subject to performance standards and quality system regulations to ensure safety and effectiveness in detecting *Streptococcus pyogenes*.

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 Group A Strep Assay - DiaSorin, ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit ..., Multicenter Clinical Evaluation of the Automated Aries Group A Strep ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Luminex Corporation

Sources (1)

  • FDA 510(k) K172402 24 fields · synced Oct 6, 2026