510(k) · Cleared
ClearedAmpliVue Bordetella Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · OZZ Bordetella Pertussis Dna Assay System
Cleared on Dec 10, 2014 as substantially equivalent to K133673 (Meridian Bioscience, Inc., 2014) after a 33-day review. Its family tree reaches back 7 generations to 2008.
- Decided
- Dec 10, 2014
- Review
- 33 days
- Class
- Class II
- Product code
- OZZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN070013 (2008). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK143206 AmpliVue Bordetella AssayQuidel Corporation · 2014
View 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) | K143206 | AmpliVue Bordetella Assay | Quidel Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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 8…J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene® Pertussis DNA Amplification Assay 2. Predicate 510(k) number(s): K133673 Quidel Corporation… | 2014 |
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 6 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 2 of the 8 ancestors have a recall of any class.
- 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. 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 AmpliVue® Bordetella Assay is an in vitro diagnostic test for the qualitative detection of Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The AmpliVue® Bordetella Assay utilizes helicase-dependent amplification (HDA) of the insertion sequence IS481 and a self-contained disposable amplification detection device…
Read the full statement (252 words)
The AmpliVue® Bordetella Assay is an in vitro diagnostic test for the qualitative detection of Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.
The AmpliVue® Bordetella Assay utilizes helicase-dependent amplification (HDA) of the insertion sequence IS481 and a self-contained disposable amplification detection device that allows for manual evaluation of assay results. The IS481 sequence can also be found in strains of other organisms (i.e., B. holmesii and B. bronchiseptica). 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 AmpliVue® Bordetella Assay do not preclude B. pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the AmpliVue® Bordetella 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.
The AmpliVue® Bordetella Assay 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/K143206 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143206: AmpliVue Bordetella Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143206
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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