Cleared Special

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch

K160457 · Biofire Diagnostics, LLC · Microbiology

Mar 2016

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K160457 is an FDA 510(k) clearance for the FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch, a Gram-negative Bacteria And Associated Resistance Markers (Class II — Special Controls, product code PEN), submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on March 15, 2016, 25 days after receiving the submission on February 19, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K160457 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2016
Decision Date	March 15, 2016
Days to Decision	25 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PEN — Gram-negative Bacteria And Associated Resistance Markers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3365
Definition	A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures.