510(k) · Cleared
ClearedGreat Basin Bordetella Direct Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Great Basin Scientific, Inc. · OZZ Bordetella Pertussis Dna Assay System
Cleared on Mar 31, 2017 as substantially equivalent to K133673 (Meridian Bioscience, Inc., 2014) after a 60-day review. Its family tree reaches back 7 generations to 2008.
- Decided
- Mar 31, 2017
- Review
- 60 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 deviceK170284 Great Basin Bordetella Direct TestGreat Basin Scientific, Inc. · 2017
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) | K170284 | Great Basin Bordetella Direct Test | Great Basin Scientific, Inc. | 2017 | — |
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 6…510(k) Great Basin Bordetella Direct Test F. Substantial Equivalence Information: Predicate Device: illumigene® Pertussis DNA Amplification Assay (K133673) The following table provides a comparison of the Bordetella Direct Test and the predicate device:… | 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 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.
- 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 Great Basin Bordetella Direct Test is a qualitative in vitro diagnostic test for the detection of Bordetella pertussis DNA from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to B. pertussis. The Bordetella Direct Test is performed on the PA500 Portrait Analyzer and utilizes PCR amplification of the insertion sequence IS481. The IS481 sequence is also found in other organisms…
Read the full statement (241 words)
The Great Basin Bordetella Direct Test is a qualitative in vitro diagnostic test for the detection of Bordetella pertussis DNA from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to B. pertussis.
The Bordetella Direct Test is performed on the PA500 Portrait Analyzer and utilizes PCR amplification of the insertion sequence IS481. The IS481 sequence is also found in other organisms including Bordetella holmesii or Bordetella bronchiseptica. Respiratory infection with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results with 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 Great Basin Bordetella Direct Test do not preclude B. pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Great Basin Bordetella Direct Test 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.
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/K170284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170284: Great Basin Bordetella Direct Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170284
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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