510(k) · Cleared
ClearedPanther Fusion GI Expanded Bacterial Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Sep 25, 2025 as substantially equivalent to K160459 (Biofire Diagnostics, LLC, 2016) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 2013.
- Decided
- Sep 25, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- PCH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to DEN130003 (2013). No later device cites it as a predicate yet.
- Root · 4 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 3 generations backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- 2 generations backK143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · Recalled
- 1 generation backK160459 FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- This deviceK251993 Panther Fusion GI Expanded Bacterial AssayHologic, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −3 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| −2 | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015 | 7 |
| −1 | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 6 |
| 0 (this device) | K251993 | Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. | 2025 | — |
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 PCH? 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 PCH device
- #1 K220062 QIAstat-Dx Gastrointestinal Panel 2score 16.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchSummary page 5…PCH and OOI III. PREDICATE DEVICE The predicate device for the Panther Fusion GI Expanded Bacterial Assay is the BioFire FilmArray Gastrointestinal (GI) Panel (K160459, K143005 & K140407). 510(k) Summary Original 510(k) Application Confidential IV. DEVICE D… | 2016 |
| * | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Summary page 5…and OOI III. PREDICATE DEVICE The predicate device for the Panther Fusion GI Expanded Bacterial Assay is the BioFire FilmArray Gastrointestinal (GI) Panel (K160459, K143005 & K140407). 510(k) Summary Original 510(k) Application Confidential IV. DEVICE DESCRIPTIO… | 2015 |
| * | K140407 | Filmarray Gastrointestinal (GI) PanelSummary page 5…III. PREDICATE DEVICE The predicate device for the Panther Fusion GI Expanded Bacterial Assay is the BioFire FilmArray Gastrointestinal (GI) Panel (K160459, K143005 & K140407). 510(k) Summary Original 510(k) Application Confidential IV. DEVICE DESCRIPTION The Pant… | 2014 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K160459.
How does its category compare?
All PCH devicesPCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PCH
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PCH
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCH
5in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PCH
40in 2025
MAUDE reports naming product code PCH, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 3 | — | 0 | 0 |
| 2014 | 6 | 120 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 4 | 105 | 0 | 0 |
| 2019 | 4 | 191 | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 2 | — | 0 | 47 |
| 2023 | 1 | — | 1 | 62 |
| 2024 | 3 | 271 | 0 | 45 |
| 2025 | 7 | 89 | 5 | 40 |
| 2026 | 3 | 176 | 0 | — |
What is it indicated for?
The Panther Fusion GI Expanded Bacterial Assay is a multiplex real-time PCR in vitro diagnostic test for the rapid and qualitative detection and differentiation of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides. Nucleic acids are isolated and purified from Cary-Blair preserved stool specimens collected from individuals exhibiting signs and symptoms of gastroenteritis.…
Read the full statement (200 words)
The Panther Fusion GI Expanded Bacterial Assay is a multiplex real-time PCR in vitro diagnostic test for the rapid and qualitative detection and differentiation of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides. Nucleic acids are isolated and purified from Cary-Blair preserved stool specimens collected from individuals exhibiting signs and symptoms of gastroenteritis.
This assay is intended to aid in the differential diagnosis of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides infections. The results of this assay should be used in conjunction with clinical presentation, laboratory findings, and epidemiological information and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out coinfection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test, or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn’s disease. 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/K251993 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251993: Panther Fusion GI Expanded Bacterial Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251993
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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