510(k) Report

De Novo · Granted

Granted

ID-Tag Respiratory Viral Panel

DEN070013De NovoGranted Jan 3, 200830-day reviewClass II21 CFR 866.3980

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

Luminex Molecular Diagnostics, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System

Granted on Jan 3, 2008 as a new device type through De Novo after a 30-day review. 106 later devices descend from it.

Decided
Jan 3, 2008
Review
30 days
Class
Class II
Product code
OCC
Recalls
None

106 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2011: 9 descendants cleared2009: 8 descendants cleared2010: 4 descendants cleared2008: 3 descendants cleared2012: 10 descendants cleared2016: 8 descendants cleared2015: 9 descendants cleared2013: 13 descendants cleared2014: 7 descendants cleared2017: 13 descendants cleared2019: 5 descendants cleared2023: 4 descendants cleared2025: 1 descendant cleared2020: 1 descendant cleared2018: 5 descendants cleared2021: 1 descendant cleared2026: 3 descendants cleared2022: 2 descendants cleared20052010201520202025
  1. This deviceDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
  2. Descendant · cites it directly · 91 of its ownK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
  3. Descendant · 2 generations on · 89 of its ownK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
  4. Descendant · cites it directly · 45 of its ownK081030 Modification to Proflu+ AssayProdesse, Inc. · 2008
  5. Descendant · 2 generations on · 41 of its ownK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
  6. Descendant · cites it directly · 34 of its ownK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010

Showing 5 of 106 descendants. See all descendants

Descendants cleared per year

2008: 32009: 82010: 42011: 92012: 102013: 132014: 72015: 92016: 82017: 132018: 52019: 52020: 12021: 12022: 22023: 42025: 12026: 3
2008high 13 (2013) · low 0 (2024)2026

Most influential descendants

Showing 5 of 106 · See all
  • K081483Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · cites it directly91descendants
  • K091667Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116Luminex Molecular Diagnostics, Inc. · 2009 · 2 generations on89descendants
  • K081030Modification to Proflu+ AssayProdesse, Inc. · 2008 · cites it directly45descendants
  • K092500Modification to Proflu+ AssayProdesse, Inc. · 2009 · 2 generations on41descendants
  • K100148Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010 · cites it directly34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN070013ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.2008—
+1K081483Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.20081
+2K091667Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc.20091
+1K081030Modification to Proflu+ AssayProdesse, Inc.2008—
+2K092500Modification to Proflu+ AssayProdesse, Inc.2009—
+1K100148Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200830
200980
201040
201190
2012100
2013130
201470
201590
201680
2017130
201850
201950
202010
202110
202220
202340
202510
202630
FIG. 1 — Lineage of DEN070013, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA De Novo database (decision fields), 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. #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (106)

See all 106

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081483Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.200891
K081030Modification to Proflu+ AssayProdesse, Inc.200845
K100148Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc.201034
K103175Filmarray Respiratory Panel (RP)Idaho Technology, Inc.201123
K110764Filmarray RP PanelIdaho Technology, Inc.201122
K110968Proflu+ AssayGen-Probe Prodesse, Inc.201115
K082688Pro HMPV+ AssayProdesse, Inc.200815
K101855Profast+ AssayGen-Probe Prodesse, Inc.20105
K091053Proparaflu+AssayProdesse, Inc.20094
K102952Prodesse ProadenoGen-Probe Prodesse, Inc.20103

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?

  • Of its descendants, K081483 (Luminex Molecular Diagnostics, Inc., 2008) has gone furthest, with 91 descendants of its own.

How does its category compare?

All OCC devices

OCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OCC

1in 2024

2008: 42009: 62010: 22011: 92012: 62013: 62014: 42015: 82016: 72017: 102018: 42019: 52020: 22021: 12022: 12023: 22024: 12026 (partial year): 3
2007high 10 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCC

31in 2019

2008: 28 days median2009: 24 days median2011: 82 days median2012: 125 days median2013: 79 days median2014: 94 days median2015: 85 days median2016: 92 days median2017: 136 days median2018: 134 days median2019: 31 days median2026 (partial year): 130 days median
2007high 136 (2017) · low 24 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCC

1in 2024

2014: 12018: 12019: 12024: 1
2007high 1 (2014) · low 0 (2007)2026

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

Adverse event reports per year · OCC

2in 2025

2011: 22012: 12014: 522015: 12016: 362017: 12018: 12019: 22020: 172021: 6862022: 22023: 12024: 32025: 2
2007high 686 (2021) · low 0 (2007)2025

MAUDE reports naming product code OCC, 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
200842800
200962400
20102—00
201198202
2012612501
201367900
2014494152
201588501
2016792036
20171013601
2018413411
201953112
20202—017
20211—0686
20221—02
20232—01
20241—13
20250—02
202631300—

More from Luminex Molecular Diagnostics, Inc.

26 FDA decisions under this applicant name. See the company

  • K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc. · 2024
  • K231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)Luminex Molecular Diagnostics, Inc. · 2024
  • K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareLuminex Molecular Diagnostics, Inc. · 20191 recall
  • K191161xTAG Gastrointestinal Pathogen Panel (GPP)Luminex Molecular Diagnostics, Inc. · 2019
  • K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc. · 2019

Recent decisions in OCC

The OCC category page

  • K261347DASH Flu A/B TestNuclein, LLC · 2026
  • K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc. · 2026
  • K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc. · 2026
  • K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc. · 2024
  • K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc. · 20232 recalls

https://510kreport.com/device/DEN070013 · printed Nov 5, 2026

Cite this page

510(k) Report. “DEN070013: ID-Tag Respiratory Viral Panel.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN070013

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026