# K113731: Esensor Respiratory Viral Panel

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Micro Sensors, Inc.
- Decided: Sep 10, 2012 after 266 days
- Product code: JJH (Clinical Sample Concentrator)
- Device class: 1
- Regulation: 21 CFR 862.2310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN070013 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081483: Xtag Respiratory Viral Panel, Luminex Molecular Diagnostics, Inc. (2008) Summary page 1.
- K073720: Esensor Warfarin Sensitivity and XT-8 Instrument, Osmetech Molecular Diagnostics (2008) Summary page 1.

## Indications for use
The eSensorIO Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex In vitro diagnostic test intended for use on the eSensor XT-8TM system for the simultaneous detection and identification of multiple respiratory viral nucleic acids in nasopharyngeat swabs (NPS) obtained from individuals exhibiting signs and symptoms of respiratory Infection. The following virus types and subtypes are identified using the eSensor RVP: Influenza A, Influenza A Hi Seasonal Subtype. Influenza A H3 Seasonal Subtype, Influenza A 2009 Hi NI subtype, Influerna B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza Virus 1, Parainfluenza Virus 2. Parainfluonza Virus 3. Human Metapneuniovirus, Human Rhinovirus, Adenovinis species BWE,and Adenovirus species C. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral Infection if used inconjunction with other clinical and epidemiological information. Negative results do not preclude respiratory viral Infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive results do not rule out bacterial infection, or co-ifection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence and radiography) and clinical presentation must be taken Into consideration in the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A were established during the 2010/2011 influenza season when Influenzam A 2009 H1iN and H3N2 were the predominant Influenza Aviruses in circulation. When other Influenza A viruses emerge, performance characteristics may vary. If infection with a novel Influenzta A virus issuspected 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 stale or local health departments for testing. Viral culture should not be attempted in these cases unless a BSIL 3+ facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K113731
Methodology: https://510kreport.com/methodology