# K103209: Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Jan 10, 2011 after 70 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN070013 (2008). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092566: Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp), Nanosphere, Inc. (2009) Summary page 4.
- K101855: Profast+ Assay, Gen-Probe Prodesse, Inc. (2010) Summary page 4.

## Most influential descendants
- K163628: Idylla Respiratory (IFV-RSV) Panel (2017), 0 descendants of its own
- K131584: Imdx Flu a/B and RSV for Abbott M2000 (2013), 0 descendants of its own

## Recalls of this device
- Oct 10, 2013 · Class II · Z-2684-2014: 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 pro

## Indications for use
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.

Source page: https://510kreport.com/device/K103209
Methodology: https://510kreport.com/methodology