Cleared Special

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

K160459 · Biofire Diagnostics, LLC · Microbiology

Apr 2016

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K160459 is an FDA 510(k) clearance for the FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch, 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 April 1, 2016, 42 days after receiving the submission on February 19, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K160459 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2016
Decision Date	April 01, 2016
Days to Decision	42 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.