Cleared Traditional

Panther Fusion GI Expanded Bacterial Assay

K251993 · Hologic, Inc. · Microbiology

Sep 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K251993 is an FDA 510(k) clearance for the Panther Fusion GI Expanded Bacterial Assay, a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (Class II — Special Controls, product code PCH), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on September 25, 2025, 90 days after receiving the submission on June 27, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K251993 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2025
Decision Date	September 25, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3990
Definition	A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation And Other Laboratory Findings.