510(k) · Cleared
Clearedcobas liat Bordetella panel nucleic acid test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · OZZ Bordetella Pertussis Dna Assay System
Cleared on Nov 20, 2025 as substantially equivalent to K143653 (Nanosphere, Inc., 2015) after a 350-day review. Its family tree reaches back 8 generations to 2008.
- Decided
- Nov 20, 2025
- Review
- 350 days
- Class
- Class II
- Product code
- OZZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to DEN070013 (2008). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 7 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 6 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 5 generations backK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
- 4 generations backK120267 Filmarray RP PanelIdaho Technology, Inc. · 2012
- 3 generations backK123620 Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc. · 2013
- 2 generations backK143080 FilmArray Respiratory Panel (RP) for use with Multi-instrument…Biofire Diagnostics, LLC · 2015
- 1 generation backK143653 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc. · 2015 · Recalled
- This deviceK243753 cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −7 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −6 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −5 | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | — |
| −4 | K120267 | Filmarray RP Panel | Idaho Technology, Inc. | 2012 | — |
| −3 | K123620 | Filmarray Respiratory Panel (RP) | Biofire Diagnostics, Inc. | 2013 | — |
| −2 | K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | Biofire Diagnostics, LLC | 2015 | — |
| −1 | K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | Nanosphere, Inc. | 2015 | 5 |
| 0 (this device) | K243753 | cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. | 2025 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Summary page 5…OOI Verigene® Respiratory Pathogens Flex Nucleic Acid Test (Verigene® RP Flex) Predicate Devices (K143653) Establishment Registration Roche Molecular Systems, Inc. (2243471)… | 2015 |
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 17 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 9 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. 2025, 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 cobas liat Bordetella panel nucleic acid test (cobas liat Bordetella panel) is an automated real-time polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of Bordetella pertussis (Bp), Bordetella parapertussis (Bpp), and Bordetella holmesii (Bh) nucleic acid in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection. The test is meant to be used in…
Read the full statement (155 words)
The cobas liat Bordetella panel nucleic acid test (cobas liat Bordetella panel) is an automated real-time polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of Bordetella pertussis (Bp), Bordetella parapertussis (Bpp), and Bordetella holmesii (Bh) nucleic acid in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection.
The test is meant to be used in conjunction with other clinical and epidemiological information and laboratory findings. When clinical factors suggest that B. pertussis, B. parapertussis or B. holmesii may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.
Negative results do not preclude Bp, Bpp, or Bh infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out co-infection with other bacteria or viruses. The agent detected may not be the definite cause of disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243753 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243753: cobas liat Bordetella panel nucleic acid test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243753
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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