510(k) · Cleared
Recalled · Class II · 2019ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Corporation · OZN C. Difficile Toxin Gene Amplification Assay
Cleared on Jul 21, 2017 as substantially equivalent to K123998 (Quidel Corp., 2013) after a 66-day review. Its family tree reaches back 1 generation to 2013. It has been recalled once.
- Decided
- Jul 21, 2017
- Review
- 66 days
- Class
- Class II
- Product code
- OZN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123998 (2013). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK123998 Quidel Molecular Direct C. Difficile AssayQuidel Corp. · 2013
- This deviceK171441 ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay…Luminex Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123998 | Quidel Molecular Direct C. Difficile Assay | Quidel Corp. | 2013 | — |
| 0 (this device) | K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File… | Luminex Corporation | 2017 | — |
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 OZN? 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 OZN device
- #1 K260045 cobas® Cdiff Nucleic acid test for use on the…score 13.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K123998 | Quidel Molecular Direct C. Difficile AssaySummary page 6…Substantial Equivalence Information: 1. Predicate device name(s): Quidel Molecular Direct C. difficile Assay 2. Predicate 510(k) number(s): K123998 3. Comparison with predicate: The following tables compare Luminex’s ARIES® C. difficile Assay to Quidel’s… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2019 | Class II | Z-2287-2019 | Process control | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K123998.
How does its category compare?
All OZN devicesOZN C. Difficile Toxin Gene Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OZN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZN
89in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OZN
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OZN
3in 2025
MAUDE reports naming product code OZN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 4 | 79 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 5 | 89 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 1 | 7 |
| 2025 | 1 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ARIES C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of toxigenic Clostridium difficile (C. difficile) nucleic acid in unpreserved, unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile infection (CDI). The test targets the C. difficile toxin A gene (tcdA) and toxin B gene (tcdB) and is indicated for use as an aid in the diagnosis of C. difficile infection (CDI).
The ARIES C. difficile Assay is indicated for use with ARIES Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171441: ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171441
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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