510(k) Report

510(k) · Cleared

Cleared

Panther Fusion AdV/hMPV/RV Assay

K231017510(k) SpecialCleared May 5, 202325-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

Hologic, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System

Cleared on May 5, 2023 as substantially equivalent to K172629 (Hologic, Inc., 2017) after a 25-day review. Its family tree reaches back 10 generations to 2008.

Decided
May 5, 2023
Review
25 days
Class
Class II
Product code
OCC
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to DEN070013 (2008). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestorDEN070013 · ID-Tag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 2008K081483 · Xtag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 2008 · recalledK091667 · Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116 · Luminex Molecular Diagnostics, Inc. · 2009 · recalledK103175 · Filmarray Respiratory Panel (RP) · Idaho Technology, Inc. · 2011K120267 · Filmarray RP Panel · Idaho Technology, Inc. · 2012K123620 · Filmarray Respiratory Panel (RP) · Biofire Diagnostics, Inc. · 2013K143080 · FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System · Biofire Diagnostics, LLC · 2015K160068 · FilmArray Respiratory Panel (RP) for use with FilmArray Torch · Biofire Diagnostics, LLC · 2016 · recalledK170604 · FilmArray Respiratory Panel 2 (RP2) · Biofire Diagnostics, LLC · 2017K172629 · Panther Fusion AdV/hMPV/RV Assay · Hologic, Inc. · 201720052010201520202025
Other ancestors, by generation 6 generations back: 1 other ancestor K172629 · Panther Fusion AdV/hMPV/RV Assay · Hologic, Inc. · 2017K170604 · FilmArray Respiratory Panel 2 (RP2) · Biofire Diagnostics, LLC · 2017K160068 · FilmArray Respiratory Panel (RP) for use with FilmArray Torch · Biofire Diagnostics, LLC · 2016 · recalledK143080 · FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System · Biofire Diagnostics, LLC · 2015K123620 · Filmarray Respiratory Panel (RP) · Biofire Diagnostics, Inc. · 2013K120267 · Filmarray RP Panel · Idaho Technology, Inc. · 2012K103175 · Filmarray Respiratory Panel (RP) · Idaho Technology, Inc. · 2011K091667 · Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116 · Luminex Molecular Diagnostics, Inc. · 2009 · recalledK081483 · Xtag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 2008 · recalledDEN070013 · ID-Tag Respiratory Viral Panel · Luminex Molecular Diagnostics, Inc. · 2008−10−50
  1. Root · 10 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
  2. 6 generations between
  3. 3 generations backK160068 FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
  4. 2 generations backK170604 FilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLC · 2017
  5. 1 generation backK172629 Panther Fusion AdV/hMPV/RV AssayHologic, Inc. · 2017
  6. This deviceK231017 Panther Fusion AdV/hMPV/RV AssayHologic, Inc. · 2023
Show all 10 generations
  1. Root · 10 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
  2. 9 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
  3. 8 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
  4. 7 generations backK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
  5. 6 generations backK120267 Filmarray RP PanelIdaho Technology, Inc. · 2012
  6. 5 generations backK123620 Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc. · 2013
  7. 4 generations backK143080 FilmArray Respiratory Panel (RP) for use with Multi-instrument…Biofire Diagnostics, LLC · 2015
  8. 3 generations backK160068 FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
  9. 2 generations backK170604 FilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLC · 2017
  10. 1 generation backK172629 Panther Fusion AdV/hMPV/RV AssayHologic, Inc. · 2017
  11. This deviceK231017 Panther Fusion AdV/hMPV/RV AssayHologic, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10DEN070013ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.2008—
−9K081483Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.20081
−8K091667Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc.20091
−7K103175Filmarray Respiratory Panel (RP)Idaho Technology, Inc.2011—
−6K120267Filmarray RP PanelIdaho Technology, Inc.2012—
−5K123620Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc.2013—
−4K143080FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray SystemBiofire Diagnostics, LLC2015—
−3K160068FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC20161
−2K170604FilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLC2017—
−1K172629Panther Fusion AdV/hMPV/RV AssayHologic, Inc.2017—
0 (this device)K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K231017, 2008–2023Source: 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 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 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

What was it cleared against? (1)

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
*K172629Panther Fusion AdV/hMPV/RV Assay
Summary page 4
…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K172629 11 Panther Fusion AdV/hMPV/RV Assay…
Hologic, Inc.2017—

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 15 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 3 of the 11 ancestors have a recall of any class.

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. 2023, 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—

What is it indicated for?

The Panther Fusion" AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. This assay is intended to aid in the differential…

Read the full statement (111 words)

The Panther Fusion" AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.

This assay is intended to aid in the differential diagnosis of Adenovirus, human Metapneumovirus, and Rhinovirus infections in humans. Negative results do not preclude Adenovirus, human Metapneumovirus, and Rhinovirus infections and should not be used as the sole basis for treatment or other management decisions. This assay is designed for use on the Panther Fusion system.

Indications for use as stated in the FDA summary.

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463 FDA decisions under this applicant name. See the company

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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/K231017 · printed Nov 5, 2026

Cite this page

510(k) Report. “K231017: Panther Fusion AdV/hMPV/RV Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231017

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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