510(k) · Cleared
Recalled · Class II · 2019ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Corporation · OZZ Bordetella Pertussis Dna Assay System
Cleared on May 2, 2017 as substantially equivalent to K133673 (Meridian Bioscience, Inc., 2014) after a 131-day review. Its family tree reaches back 7 generations to 2008. 2 later devices descend from it. It has been recalled once.
- Decided
- May 2, 2017
- Review
- 131 days
- Class
- Class II
- Product code
- OZZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN070013 (2008). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 6 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 5 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 4 generations backK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
- 3 generations backK120267 Filmarray RP PanelIdaho Technology, Inc. · 2012
- 2 generations backK123620 Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc. · 2013
- 1 generation backK133673 Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis…Meridian Bioscience, Inc. · 2014
- This deviceK163626 ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation · 2017
- Descendant · cites it directly · 1 of its ownK173498 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK183223 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −6 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −5 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −4 | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | — |
| −3 | K120267 | Filmarray RP Panel | Idaho Technology, Inc. | 2012 | — |
| −2 | K123620 | Filmarray Respiratory Panel (RP) | Biofire Diagnostics, Inc. | 2013 | — |
| −1 | K133673 | Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External… | Meridian Bioscience, Inc. | 2014 | — |
| 0 (this device) | K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | Luminex Corporation | 2017 | — |
| +1 | K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018 | — |
| +2 | K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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 OZZ? 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 OZZ device
- #1 K243753 cobas liat Bordetella panel nucleic acid testscore 12.5 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K133673 | Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit…Summary page 6…1. Predicate device name(s): illumigene® Pertussis DNA Amplification Assay (manufactured by Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: The following table compares the ARIES® Bordetella Assay to Meridian Bioscience, Inc.’s… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | 2018 | 1 |
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-2282-2019 | 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?
- The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K173498 (Diasorin Molecular, LLC, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K133673.
How does its category compare?
All OZZ devicesOZZ Bordetella Pertussis Dna Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OZZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZZ
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OZZ
No recall names OZZ since 2007.
Adverse event reports per year · OZZ
No MAUDE report names OZZ since 2007.
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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 88 | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES® Bordetella Assay…
Read the full statement (185 words)
The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.
The ARIES® Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis 131001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.
Negative results for the ARIES® Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information.
The ARIES® Bordetella Assay is indicated for use with the ARIES® Systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163626: ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163626
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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