← Back to catalogue

ARIES MRSA Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191742

by Luminex Corporation

Identifiers

510(k) Number
K191742 FDA 510(k)
FDA Product Code
NQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1640 FDA 510(k)
Regulation Number
866.1640 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Aries MRSA Assay is a nucleic acid amplification test (DNA, methicillin-resistant Staphylococcus aureus, direct specimen) classified as a System under FDA’s 510(k) pathway. It is a real-time PCR-based in vitro diagnostic device designed for the qualitative detection of MRSA DNA in nasal swab specimens, aiding microbiological identification of colonization risk in patients.

This assay is supplied as a single-use, non-sterile reagent kit intended for use in clinical microbiology laboratories. It is regulated under FDA’s 510(k) clearance (K191742) and falls under Class II medical devices (regulation number 866.1640). Storage and handling conditions must adhere to manufacturer guidelines to ensure test integrity, with no explicit MRI safety or reuse specifications noted in regulatory filings.

Frequently asked questions

What is the primary purpose of the ARIES MRSA Assay in clinical settings?

The ARIES MRSA Assay is designed to qualitatively detect methicillin-resistant *Staphylococcus aureus* (MRSA) DNA directly from nasal swab specimens. It aids microbiology laboratories in identifying patients who may be colonized with MRSA, helping to inform infection control and prevention strategies.

Is the ARIES MRSA Assay intended for single-use or repeated use, and is it sterile?

The ARIES MRSA Assay is supplied as a single-use, non-sterile reagent kit. This means each kit is meant for one test procedure and should not be reused. The non-sterile designation indicates it is not intended for invasive procedures or sterile environments, but proper handling per manufacturer guidelines is still required to maintain test integrity.

What type of specimen is required for the ARIES MRSA Assay, and how is it classified under FDA regulations?

The ARIES MRSA Assay is specifically designed for nasal swab specimens. It is classified as a System under the FDA’s 510(k) pathway and falls under Class II medical devices (regulation number 866.1640), indicating it is a nucleic acid amplification test (NAAT) for direct detection of MRSA DNA.

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

While the regulatory filings do not specify exact storage conditions, the ARIES MRSA Assay must be handled according to the manufacturer’s guidelines to ensure test integrity. Since it is non-sterile and single-use, it should be stored in a way that prevents contamination and degradation of reagents, typically at room temperature or as directed by Luminex Corporation.

What regulatory pathway was used for FDA clearance of the ARIES MRSA Assay, and what does this mean for its use?

The ARIES MRSA Assay received FDA clearance through a Traditional 510(k) pathway, determined to be Substantially Equivalent (SESE) to a predicate device. This means the FDA reviewed it against existing, legally marketed devices in the same category (Nucleic Acid Amplification Tests for MRSA detection) and confirmed it meets safety and effectiveness standards for clinical microbiology use.

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: ARIES® MRSA Assay 50-10034 The ARIES® MRSA Assay is… - FDA.report, AccessGUDID - DEVICE: ARIES® MRSA Assay (00840487101445), ARIES MRSA Assay (K191742) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Luminex Corporation

Sources (1)

  • FDA 510(k) K191742 24 fields · synced Oct 6, 2026