Cleared Special

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

K243759 · Biofire Diagnostics, LLC · Microbiology

Dec 2024

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K243759 is an FDA 510(k) clearance for the BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)), 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 December 20, 2024, 14 days after receiving the submission on December 6, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K243759 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2024
Decision Date	December 20, 2024
Days to Decision	14 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.