# K251868: Panther Fusion GI Bacterial Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hologic
- Decided: Sep 25, 2025 after 99 days
- Product code: PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN130003 (2013). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160459: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch, Biofire Diagnostics, LLC (2016) Summary page 5.
- K143005: FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0, Biofire Diagnostics, LLC (2015) Summary page 5.
- K140407: Filmarray Gastrointestinal (GI) Panel, Biofire Diagnostics (2014) Summary page 5.

## Indications for use
The Panther Fusion GI Bacterial Assay is a multiplex real-time PCR in vitro diagnostic test for the rapid and qualitative detection and differentiation of Salmonella, Shigella/Enteroinvasive Escherichia coli (EIEC), Campylobacter (C. coli, C. jejuni) nucleic acids and Shiga-toxin producing Escherichia coli Shiga toxins 1 and 2 (undifferentiated) genes. 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 Salmonella, Campylobacter, Shigella/Enteroinvasive E. coli (EIEC) and Shigatoxigenic Escherichia coli (STEC) 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 co-infection 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.

Source page: https://510kreport.com/device/K251868
Methodology: https://510kreport.com/methodology