510(k) · Cleared
Recalled · Class II · 2013Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)
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 Jan 10, 2011 as substantially equivalent to K092566 (Nanosphere, Inc., 2009) and 1 other predicate after a 70-day review. Its family tree reaches back 5 generations to 2008. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 10, 2011
- Review
- 70 days
- Class
- Class II
- Product code
- OCC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN070013 (2008). 12 ancestors in all, the oldest DEN060008 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 4 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 3 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 2 generations backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- 1 generation backK101855 Profast+ AssayGen-Probe Prodesse, Inc. · 2010
- This deviceK103209 Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK163628 Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV · 2017
- Descendant · cites it directly · 0 of its ownK131584 Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −4 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −3 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −2 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| −1 | K101855 | Profast+ Assay | Gen-Probe Prodesse, Inc. | 2010 | — |
| 0 (this device) | K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+) | Nanosphere, Inc. | 2011 | — |
| +1 | K163628 | Idylla Respiratory (IFV-RSV) Panel | Janssen Pharmaceutica NV | 2017 | — |
| +1 | K131584 | Imdx Flu a/B and RSV for Abbott M2000 | Intelligent Medical Devices, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K092566 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp)Summary page 4…3 of i13 Two cleared predicate devices were utilized: the Verigene® Respiratory Virus Nucleic Acid Test (RVNATsp; K092566) and the Prodesse ProFAST+ assay (K101 855). The RVNATsp is a multiplex in vitro diagnostic test Predicate for the rapid a… | 2009 |
| * | K101855 | Profast+ AssaySummary page 4…Two cleared predicate devices were utilized: the Verigene® Respiratory Virus Nucleic Acid Test (RVNATsp; K092566) and the Prodesse ProFAST+ assay (K101 855). The RVNATsp is a multiplex in vitro diagnostic test Predicate for the rapid and qualitative detection and discrimination… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2013 | Class II | Z-2684-2014 | Nonconforming Material/Component | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K163628 (Janssen Pharmaceutica NV, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K092566.
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. 2011, 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 Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype Hi, Influenza A subtype H3…
Read the full statement (310 words)
The Verigene" Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype Hi, Influenza A subtype H3, 2009 Hi Ni, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings.
Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the solo basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.
Performance characteristics for Influenza A Virus were established when Influenza AIH3, /H1, and 2009 Hi Ni were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging.
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 used specifically 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/K103209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103209: Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103209
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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