510(k) Report

510(k) · Cleared

Cleared

Esensor Respiratory Viral Panel

K113731510(k) TraditionalCleared Sep 10, 2012266-day reviewClass I21 CFR 862.2310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year cleared 2008: 1 other ancestorDEN070013 · ID-Tag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 2008K081483 · Xtag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 2008 · recalled20062008201020122014
  1. Root · 2 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
  2. 1 generation backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
  3. This deviceK113731 Esensor Respiratory Viral PanelClinical Micro Sensors, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2DEN070013ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.2008—
−1K081483Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.20081
0 (this device)K113731Esensor Respiratory Viral PanelClinical Micro Sensors, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K113731, 2008–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K081483Xtag Respiratory Viral Panel
Summary 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…
Luminex Molecular Diagnostics, Inc.20081
*K073720Esensor Warfarin Sensitivity and XT-8 Instrument
Summary 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…
Osmetech Molecular Diagnostics2008—

Also cleared against K081483: 10 other devices →

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 devices

JJH 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

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

2009: 12011: 12012: 22013: 12014: 12018: 22022: 12026 (partial year): 1
2007high 2 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJH

27in 2025

2008: 12009: 22010: 22011: 32012: 82013: 52014: 782015: 142016: 62017: 62018: 212019: 102020: 122021: 202022: 452023: 102024: 122025: 27
2007high 78 (2014) · low 0 (2007)2025

MAUDE reports naming product code JJH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—12
20100—02
20110—13
20121—28
20130—15
20140—178
20150—014
20160—06
20170—06
20180—221
20190—010
20200—012
20210—020
20220—145
20230—010
20240—012
20250—027
20260—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.

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

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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