510(k) · Cleared
ClearedEsensor Respiratory Viral Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Micro Sensors, Inc. · JJH Clinical Sample Concentrator
Cleared on Sep 10, 2012 as substantially equivalent to K081483 (Luminex Molecular Diagnostics, Inc., 2008) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Sep 10, 2012
- Review
- 266 days
- Class
- Class I
- Product code
- JJH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN070013 (2008). 3 ancestors in all. No later device cites it as a predicate yet.
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 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| 0 (this device) | K113731 | Esensor Respiratory Viral Panel | Clinical Micro Sensors, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 JJH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K081483 | Xtag Respiratory Viral PanelSummary page 1…NSU: Instrumentation for clinical multiplex test systems Predicate Device(s): Luminex® xTag Tm RVP, 510(k) Number K081483 Classification Code: 0CC, OEM, QEP Regulation No. 8… | 2008 |
| * | K073720 | Esensor Warfarin Sensitivity and XT-8 InstrumentSummary page 1…Code: 0CC, OEM, QEP Regulation No. 866.3980 eSensor® Warfarin Sensitivity Test, 51 0(k) No. K073720 Classification Code (applicable): NSU Instrumentation for… | 2008 |
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 4 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 10 other devices also cite its predicate K081483.
How does its category compare?
All JJH devicesJJH Clinical Sample Concentrator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JJH
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JJH
Too few JJH 510(k)s in any year since 2007 to give a median.
Recalls per year · JJH
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJH
27in 2025
MAUDE reports naming product code JJH, 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 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 1 | — | 2 | 8 |
| 2013 | 0 | — | 1 | 5 |
| 2014 | 0 | — | 1 | 78 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 2 | 21 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 1 | 45 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (328 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113731: Esensor Respiratory Viral Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113731
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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