510(k) · Cleared
ClearedARIES MRSA Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Corporation · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cleared on Sep 25, 2019 as substantially equivalent to K133605 (Geneohm Sciences Canada, Inc., 2013) after an 86-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Sep 25, 2019
- Review
- 86 days
- Class
- Class II
- Product code
- NQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K850291 (1985). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
- 5 generations backK033415 Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004 · Recalled
- 4 generations backK070462 Xpert MrsaCepheid · 2007 · Recalled
- 3 generations backK093346 BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · Recalled
- 2 generations backK120138 BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · Recalled
- 1 generation backK133605 BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 2013 · Recalled
- This deviceK191742 ARIES MRSA AssayLuminex Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| −5 | K033415 | Idi-Mrsa | Infectio Diagnostic (I.D.I.), Inc. | 2004 | 1 |
| −4 | K070462 | Xpert Mrsa | Cepheid | 2007 | 1 |
| −3 | K093346 | BD Geneohm Mrsa Acp Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009 | 2 |
| −2 | K120138 | BD Max Mrsa Assay, BD Max Instrument | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012 | 4 |
| −1 | K133605 | BD Max Mrsa XT, BD Max Instrument | Geneohm Sciences Canada, Inc. | 2013 | 1 |
| 0 (this device) | K191742 | ARIES MRSA Assay | Luminex Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQX device
- #1 K243625 Xpert MRSA/SA SSTIscore 9.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133605 | BD Max Mrsa XT, BD Max InstrumentSummary page 6…of 21 ARIES® MRSA Assay 510(k) Summary 2. Predicate 510(k) number(s): K133605 3. Comparison with predicate: The following tables compare Luminex’s ARIES® MRSA Assay to GeneOhm Sciences… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 7 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K133605.
How does its category compare?
All NQX devicesNQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NQX
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQX
75in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQX
15in 2025
MAUDE reports naming product code NQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 3 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 70 | 1 | 1 |
| 2011 | 2 | — | 6 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 4 | 75 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 2 | — | 0 | 8 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (117 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191742: ARIES MRSA Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191742
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026