Cleared Special

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

K243885 · Biofire Diagnostics, LLC · Microbiology

Jan 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K243885 is an FDA 510(k) clearance for the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid, a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (Class II — Special Controls, product code PCH), submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on January 16, 2025, 29 days after receiving the submission on December 18, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K243885 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2024
Decision Date	January 16, 2025
Days to Decision	29 days
Submission Type	Special
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.