510(k) · Cleared
ClearedPanther Fusion AdV/hMPV/RV Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Dec 4, 2017 as substantially equivalent to K170604 (Biofire Diagnostics, LLC, 2017) after a 94-day review. Its family tree reaches back 9 generations to 2008. 1 later device descends from it.
- Decided
- Dec 4, 2017
- Review
- 94 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to DEN070013 (2008). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 5 generations between
- 3 generations backK143080 FilmArray Respiratory Panel (RP) for use with Multi-instrument…Biofire Diagnostics, LLC · 2015
- 2 generations backK160068 FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- 1 generation backK170604 FilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLC · 2017
- This deviceK172629 Panther Fusion AdV/hMPV/RV AssayHologic, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK231017 Panther Fusion AdV/hMPV/RV AssayHologic, Inc. · 2023
Show all 9 generations
- Root · 9 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 8 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 7 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 6 generations backK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
- 5 generations backK120267 Filmarray RP PanelIdaho Technology, Inc. · 2012
- 4 generations backK123620 Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc. · 2013
- 3 generations backK143080 FilmArray Respiratory Panel (RP) for use with Multi-instrument…Biofire Diagnostics, LLC · 2015
- 2 generations backK160068 FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- 1 generation backK170604 FilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLC · 2017
- This deviceK172629 Panther Fusion AdV/hMPV/RV AssayHologic, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −8 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −7 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −6 | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | — |
| −5 | K120267 | Filmarray RP Panel | Idaho Technology, Inc. | 2012 | — |
| −4 | K123620 | Filmarray Respiratory Panel (RP) | Biofire Diagnostics, Inc. | 2013 | — |
| −3 | K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | Biofire Diagnostics, LLC | 2015 | — |
| −2 | K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 1 |
| −1 | K170604 | FilmArray Respiratory Panel 2 (RP2) | Biofire Diagnostics, LLC | 2017 | — |
| 0 (this device) | K172629 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2017 | — |
| +1 | K231017 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170604 | FilmArray Respiratory Panel 2 (RP2)Summary page 4…570 Regulatory Class: Class II Product Code: OEM and OCC III. PREDICATE DEVICE The predicate device is the FilmArray® Respiratory Panel 2 (RP2) (K170604; cleared May 30, 2017, BioFire Diagnostics, LLC, Salt Lake City, UT). IV. DEVICE DESCRIPTION The Panther Fusion AdV/hMPV/RV ass… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231017 | Panther Fusion AdV/hMPV/RV Assay | 2023 | 0 |
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 9 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K231017 (Hologic, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K170604.
How does its category compare?
All OCC devicesOCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCC
31in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCC
2in 2025
MAUDE reports naming product code OCC, 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 | 4 | 28 | 0 | 0 |
| 2009 | 6 | 24 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 9 | 82 | 0 | 2 |
| 2012 | 6 | 125 | 0 | 1 |
| 2013 | 6 | 79 | 0 | 0 |
| 2014 | 4 | 94 | 1 | 52 |
| 2015 | 8 | 85 | 0 | 1 |
| 2016 | 7 | 92 | 0 | 36 |
| 2017 | 10 | 136 | 0 | 1 |
| 2018 | 4 | 134 | 1 | 1 |
| 2019 | 5 | 31 | 1 | 2 |
| 2020 | 2 | — | 0 | 17 |
| 2021 | 1 | — | 0 | 686 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 3 | 130 | 0 | — |
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.
https://510kreport.com/device/K172629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172629: Panther Fusion AdV/hMPV/RV Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172629
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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