510(k) · Cleared
ClearedVerigene Respiratory Virus Nucleic Acid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosphere, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on May 1, 2009 as substantially equivalent to K073029 (Prodesse, Inc., 2008) and 1 other predicate after a 197-day review. Its family tree reaches back 2 generations to 2008. 5 later devices descend from it.
- Decided
- May 1, 2009
- Review
- 197 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN070013 (2008). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 1 generation backK081030 Modification to Proflu+ AssayProdesse, Inc. · 2008
- This deviceK083088 Verigene Respiratory Virus Nucleic Acid TestNanosphere, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK092566 Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP…Nanosphere, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK103209 Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 0 of its ownK163628 Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV · 2017
- Descendant · 3 generations on · 0 of its ownK131584 Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK123197 Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc. · 2012 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K092566Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp)Nanosphere, Inc. · 2009 · cites it directly4descendants
- K103209Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc. · 2011 · 2 generations on2descendants
- K163628Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV · 2017 · 3 generations on0descendants
- K131584Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc. · 2013 · 3 generations on0descendants
- K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −1 | K081030 | Modification to Proflu+ Assay | Prodesse, Inc. | 2008 | — |
| 0 (this device) | K083088 | Verigene Respiratory Virus Nucleic Acid Test | Nanosphere, Inc. | 2009 | — |
| +1 | K092566 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp) | Nanosphere, Inc. | 2009 | — |
| +2 | K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+) | Nanosphere, Inc. | 2011 | 1 |
| +3 | K163628 | Idylla Respiratory (IFV-RSV) Panel | Janssen Pharmaceutica NV | 2017 | — |
| +3 | K131584 | Imdx Flu a/B and RSV for Abbott M2000 | Intelligent Medical Devices, Inc. | 2013 | — |
| +2 | K123197 | Verigene C. Difficile Nucleic Acid Test (CDF) | Nanosphere, Inc. | 2012 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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 OCC? 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 OCC device
- #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K073029 | Proflu+ AssaySummary page 3…n these cases unless a BSL 3+ facility is available to receive and culture specimens. Predicate device: The Prodesse ProFlu+TM Assay [K073029 and K081030] is claimed as the predicate device for the Verigene® Respiratory Virus Nucleic Acid Test.… | 2008 |
| * | K081030 | Modification to Proflu+ AssaySummary page 3…s unless a BSL 3+ facility is available to receive and culture specimens. Predicate device: The Prodesse ProFlu+TM Assay [K073029 and K081030] is claimed as the predicate device for the Verigene® Respiratory Virus Nucleic Acid Test.… | 2008 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092566 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp) | 2009 | 4 |
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 1 year and passes through 3 companies; a new generation was cleared every 12 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K092566 (Nanosphere, Inc., 2009) has gone furthest, with 4 descendants of its own.
- 9 other devices also cite its predicate K073029.
How does its category compare?
All OCC devicesOCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCC
31in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCC
2in 2025
MAUDE reports naming product code OCC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 6 | 24 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 9 | 82 | 0 | 2 |
| 2012 | 6 | 125 | 0 | 1 |
| 2013 | 6 | 79 | 0 | 0 |
| 2014 | 4 | 94 | 1 | 52 |
| 2015 | 8 | 85 | 0 | 1 |
| 2016 | 7 | 92 | 0 | 36 |
| 2017 | 10 | 136 | 0 | 1 |
| 2018 | 4 | 134 | 1 | 1 |
| 2019 | 5 | 31 | 1 | 2 |
| 2020 | 2 | — | 0 | 17 |
| 2021 | 1 | — | 0 | 686 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 3 | 130 | 0 | — |
What is it indicated for?
The Verigene® Respiratory Virus Nucleic Acid Test is a qualitative multiplex in vitro diagnostic test 'for the detection and identification of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids purified from nasopharyngeal swab specimens obtained from patients symptomatic for viral upper respiratory infection. The test is intended to be used on the Verigene® System as an aid in the differential diagnosis of…
Read the full statement (221 words)
The Verigene® Respiratory Virus Nucleic Acid Test is a qualitative multiplex in vitro diagnostic test 'for the detection and identification of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids purified from nasopharyngeal swab specimens obtained from patients symptomatic for viral upper respiratory infection. The test is intended to be used on the Verigene® System as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV infections. The test is not intended to detect Influenza C virus.
Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative test results be confinned by culture.
Performance characteristics for Influenza A Virus were established when Influenza A/H3 and AH 1 were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
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/K083088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083088: Verigene Respiratory Virus Nucleic Acid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083088
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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