Cleared Traditional

FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0

K143005 · Biofire Diagnostics, LLC · Microbiology

Feb 2015

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K143005 is an FDA 510(k) clearance for the FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0, 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 February 19, 2015, 122 days after receiving the submission on October 20, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3990.

Submission Details

510(k) Number	K143005 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 2014
Decision Date	February 19, 2015
Days to Decision	122 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.