| K-number | K251868 |
| Device name | Panther Fusion GI Bacterial Assay |
| Applicant | Hologic |
| Product code | PCH |
| Device class | Class II |
| Decision date | Sep 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.3990 |
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/EIEC, Campylobacter, and Shiga-toxin producing E. coli from stool specimens. The assay is used by clinical laboratories to aid in the differential diagnosis of bacterial gastroenteritis infections in patients exhibiting signs and symptoms of gastrointestinal infection.
Not stated in this summary.
Not stated.
The device is regulated under 21 CFR 866.3990 as a Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay (Class II). The FDA determined substantial equivalence based on comparison to legally marketed predicates; however, the specific technical characteristics that are equivalent or different from predicates and the detailed reasoning for the substantial equivalence determination are not provided in this summary document.
View the full FDA submission: accessdata.fda.gov