Cleared Traditional

BioFire Blood Culture Identification 2 (BCID2) Panel

K193519 · Biofire Diagnostics, LLC · Microbiology

Mar 2020

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K193519 is an FDA 510(k) clearance for the BioFire Blood Culture Identification 2 (BCID2) 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 March 18, 2020, 90 days after receiving the submission on December 19, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K193519 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2019
Decision Date	March 18, 2020
Days to Decision	90 days
Submission Type	Traditional
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.