Cleared Special

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

K160462 · Biofire Diagnostics, LLC · Microbiology
Mar 2016
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K160462 is an FDA 510(k) clearance for the FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch, a Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System (Class II — Special Controls, product code PLO), submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on March 17, 2016, 27 days after receiving the submission on February 19, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3970.

Submission Details

510(k) Number K160462 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2016
Decision Date March 17, 2016
Days to Decision 27 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PLO — Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3970
Definition A Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Test For The Direct Detection And Identification Of Microbial-associated Nucleic Acids In Cerebrospinal Fluid. The Test Is Indicated For Individuals With Signs And Symptoms Of Meningitis Or Encephalitis And Aids In Diagnosis Of Agents Of Meningitis Or Encephalitis When Used In Conjunction With Clinical And Other Laboratory Findings.