510(k) · Cleared
ClearedSimplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasorin Molecular, LLC · OZZ Bordetella Pertussis Dna Assay System
Cleared on Dec 19, 2018 as substantially equivalent to K173498 (Diasorin Molecular, LLC, 2018) after a 29-day review. Its family tree reaches back 9 generations to 2008.
- Decided
- Dec 19, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- OZZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to DEN070013 (2008). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 5 generations between
- 3 generations backK133673 Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis…Meridian Bioscience, Inc. · 2014
- 2 generations backK163626 ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation · 2017 · Recalled
- 1 generation backK173498 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018
- This deviceK183223 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018
Show all 9 generations
- Root · 9 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 8 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 7 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 6 generations backK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
- 5 generations backK120267 Filmarray RP PanelIdaho Technology, Inc. · 2012
- 4 generations backK123620 Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc. · 2013
- 3 generations backK133673 Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis…Meridian Bioscience, Inc. · 2014
- 2 generations backK163626 ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation · 2017 · Recalled
- 1 generation backK173498 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018
- This deviceK183223 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −8 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −7 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −6 | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | — |
| −5 | K120267 | Filmarray RP Panel | Idaho Technology, Inc. | 2012 | — |
| −4 | K123620 | Filmarray Respiratory Panel (RP) | Biofire Diagnostics, Inc. | 2013 | — |
| −3 | K133673 | Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External… | Meridian Bioscience, Inc. | 2014 | — |
| −2 | K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | Luminex Corporation | 2017 | 1 |
| −1 | K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackSummary page 5…eric Name Bordetella nucleic acid Classification Class II Predicate Devices Simplexa™ Bordetella Direct (K173498) Intended Use Simplexa™ Bordetella Direct The DiaSorin Molecular Simplexa™ Bordetella Direct assay is an in vitro diagnostic te… | 2018 |
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 10 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 10 ancestors have a recall of any class.
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. 2018, 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?
Simplexa™ Bordetella Direct The DiaSorin Molecular Simplexa™ Bordetella Direct assay is an in vitro diagnostic test intended for use on the LIAISON® MDX instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids from nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of Bordetella infection of the respiratory tract. The Simplexa™ Bordetella Direct assay is…
Read the full statement (323 words)
Simplexa™ Bordetella Direct
The DiaSorin Molecular Simplexa™ Bordetella Direct assay is an in vitro diagnostic test intended for use on the LIAISON® MDX instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids from nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of Bordetella infection of the respiratory tract.
The Simplexa™ Bordetella Direct assay is performed on the LIAISON® MDX instrument and utilizes real-time PCR amplification to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome and to detect B. parapertussis by targeting the IS1001 insertional element of the B. parapertussis genome. The IS481 insertional element can also be present in B. holmesii and B. bronchiseptica. Specimens collected from patients with respiratory infection caused by B. pertussis, B. holmesii or B. 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 Simplexa™ Bordetella Direct assay do not preclude Bordetella infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Simplexa™ Bordetella Direct assay should be used with other clinical findings and epidemiological information as an aid in diagnosis of Bordetella infection. Test results should not be used as the sole basis for treatment or other patient management decisions.
Simplexa™ Bordetella Positive Control Pack
The Simplexa™ Bordetella Positive Control Pack is intended to be used as a control with the Simplexa™ Bordetella Direct kit.
This control is not intended for use with other assays or systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183223: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183223
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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