510(k) · Cleared
ClearedPanther Fusion Paraflu Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · OOU Parainfluenza Multiplex Nucleic Acid Assay
Cleared on Oct 23, 2017 as substantially equivalent to K153223 (Hologic, Inc., 2015) after an 87-day review. Its family tree reaches back 4 generations to 2008.
- Decided
- Oct 23, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- OOU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN070013 (2008). No later device cites it as a predicate yet.
- Root · 4 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 3 generations backK091053 Proparaflu+AssayProdesse, Inc. · 2009
- 2 generations backK132238 Proparaflu+ AssayGen-Probe Prodesse, Inc. · 2013
- 1 generation backK153223 ProParaFlu+ AssayHologic, Inc. · 2015
- This deviceK172282 Panther Fusion Paraflu AssayHologic, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −3 | K091053 | Proparaflu+Assay | Prodesse, Inc. | 2009 | — |
| −2 | K132238 | Proparaflu+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| −1 | K153223 | ProParaFlu+ Assay | Hologic, Inc. | 2015 | — |
| 0 (this device) | K172282 | Panther Fusion Paraflu Assay | Hologic, Inc. | 2017 | — |
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 OOU? 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? (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 |
|---|---|---|---|
| * | K153223 | ProParaFlu+ AssaySummary page 4…and 862.2570 Regulatory Class: Class II Product Code: OOU and OOI III. PREDICATE DEVICE The predicate device is the Prodesse ProParaFlu+ Assay (K153223; cleared December 9, 2015, Hologic, San Diego, CA). IV. DEVICE DESCRIPTION The Panther Fusion Paraflu assay is a multiplex real… | 2015 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OOU devicesOOU Parainfluenza Multiplex Nucleic Acid Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OOU
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OOU
Too few OOU 510(k)s in any year since 2007 to give a median.
Recalls per year · OOU
No recall names OOU since 2007.
Adverse event reports per year · OOU
No MAUDE report names OOU since 2007.
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 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Panther Fusion Paraflu assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus (HPIV-1, HPIV-2, HPIV-3, and HPIV-4). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract…
Read the full statement (121 words)
The Panther Fusion Paraflu assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus (HPIV-1, HPIV-2, HPIV-3, and HPIV-4). 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 HPIV-1, HPIV-2, HPIV-3, and HPIV-4 infections in humans. Negative results do not preclude HPIV-1, HPIV-2, HPIV-3, and HPIV-4 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172282: Panther Fusion Paraflu Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172282
Report an extraction error
Are you the manufacturer?
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