Cleared Traditional

FilmArray Pneumonia Panel plus

K181324 · Biofire Diagnostics, LLC · Microbiology
Nov 2018
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K181324 is an FDA 510(k) clearance for the FilmArray Pneumonia Panel plus, a Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System (Class II — Special Controls, product code QDS), submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on November 15, 2018, 181 days after receiving the submission on May 18, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.4001.

Submission Details

510(k) Number K181324 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2018
Decision Date November 15, 2018
Days to Decision 181 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QDS — Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.4001
Definition A Middle East Respiratory Syndrome Coronavirus (mers-cov) And Common Respiratory Pathogens Qualitative, Semi-quantitative Or Quantitative Multiplex Nucleic Acid Detection System Is An In Vitro Diagnostic Test For The Detection, Identification, And Quantification Of Mers-cov And Common Respiratory Pathogens ? Associated Nucleic Acids In Human Clinical Specimens. The Test Is Indicated For Individuals Meeting Specific Mers-cov Clinical And/or Epidemiological Criteria. It Aids In The Differential Diagnosis Of Mers-cov Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data, In Accordance With The Guidelines Provided By The Appropriate Public Health Authorities.