Cleared Special

FilmArray Blood Culture Identification (BCID) Panel

K181493 · Biofire Diagnostics, LLC · Microbiology

Jul 2018

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K181493 is an FDA 510(k) clearance for the FilmArray Blood Culture Identification (BCID) Panel, 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 July 5, 2018, 29 days after receiving the submission on June 6, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K181493 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2018
Decision Date	July 05, 2018
Days to Decision	29 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.