# K191742: ARIES MRSA Assay

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Corporation
- Decided: Sep 25, 2019 after 86 days
- Product code: NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K850291 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133605: BD Max Mrsa XT, BD Max Instrument, Geneohm Sciences Canada, Inc. (2013) Summary page 6.

## Indications for use
The ARIES® MRSA Assay is an integrated, real-time, polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of methicillin–resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The ARIES® MRSA Assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. The assay is not intended to guide, diagnose, or monitor treatment for MRSA infections. It is not intended to provide results of susceptibility to oxacillin/methicillin. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. The ARIES® MRSA Assay is indicated for use with ARIES® Systems.

Source page: https://510kreport.com/device/K191742
Methodology: https://510kreport.com/methodology