510(k) · Cleared
ClearedIllumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · OZZ Bordetella Pertussis Dna Assay System
Cleared on Mar 25, 2014 as substantially equivalent to K123620 (Biofire Diagnostics, Inc., 2013) and 3 other predicates after a 116-day review. Its family tree reaches back 6 generations to 2008. 5 later devices descend from it.
- Decided
- Mar 25, 2014
- Review
- 116 days
- Class
- Class II
- Product code
- OZZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to DEN070013 (2008). 7 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 5 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 4 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 3 generations backK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
- 2 generations backK120267 Filmarray RP PanelIdaho Technology, Inc. · 2012
- 1 generation backK123620 Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc. · 2013
- This deviceK133673 Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis…Meridian Bioscience, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK163626 ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK173498 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018
- Descendant · 3 generations on · 0 of its ownK183223 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018
- Descendant · cites it directly · 0 of its ownK170284 Great Basin Bordetella Direct TestGreat Basin Scientific, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK143206 AmpliVue Bordetella AssayQuidel Corporation · 2014
Most influential descendants
Showing 5 of 5 · See all- K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation · 2017 · cites it directly2descendants
- K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018 · 2 generations on1descendant
- K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018 · 3 generations on0descendants
- K170284Great Basin Bordetella Direct TestGreat Basin Scientific, Inc. · 2017 · cites it directly0descendants
- K143206AmpliVue Bordetella AssayQuidel Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −5 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −4 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −3 | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | — |
| −2 | K120267 | Filmarray RP Panel | Idaho Technology, Inc. | 2012 | — |
| −1 | K123620 | Filmarray Respiratory Panel (RP) | Biofire Diagnostics, Inc. | 2013 | — |
| 0 (this device) | K133673 | Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External… | Meridian Bioscience, Inc. | 2014 | — |
| +1 | K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | Luminex Corporation | 2017 | 1 |
| +2 | K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018 | — |
| +3 | K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018 | — |
| +1 | K170284 | Great Basin Bordetella Direct Test | Great Basin Scientific, Inc. | 2017 | — |
| +1 | K143206 | AmpliVue Bordetella Assay | Quidel Corporation | 2014 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K123620 | Filmarray Respiratory Panel (RP)Summary page 1…(21 CIFR 866.3980, Product Code OZZ) Predicate Device: FilmArray® Respiratory Panel (RP), Catalog RFIT-ASY-001 K123620, K(120267, K(110764 and K(103175, CONFIDENTIAL… | 2013 |
| * | K120267 | Filmarray RP PanelSummary page 1…(21 CIFR 866.3980, Product Code OZZ) Predicate Device: FilmArray® Respiratory Panel (RP), Catalog RFIT-ASY-001 K123620, K(120267, K(110764 and K(103175, CONFIDENTIAL… | 2012 |
| * | K110764 | Filmarray RP PanelSummary page 1…(21 CIFR 866.3980, Product Code OZZ) Predicate Device: FilmArray® Respiratory Panel (RP), Catalog RFIT-ASY-001 K123620, K(120267, K(110764 and K(103175, CONFIDENTIAL Page 1 0… | 2011 |
| * | K103175 | Filmarray Respiratory Panel (RP)Summary page 1…866.3980, Product Code OZZ) Predicate Device: FilmArray® Respiratory Panel (RP), Catalog RFIT-ASY-001 K123620, K(120267, K(110764 and K(103175, CONFIDENTIAL Page 1 005_1133673_Al… | 2011 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K163626 (Luminex Corporation, 2017) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K123620.
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. 2014, 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 illumigene® Pertussis DNA Amplification Assay, performed on the illumipro-IO™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by…
Read the full statement (270 words)
The illumigene® Pertussis DNA Amplification Assay, performed on the illumipro-IO™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.
The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis 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 illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.
illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133673: Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133673
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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