Cleared Traditional

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

K182619 · Genmark Diagnostics, Incorporated · Microbiology

Apr 2019

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K182619 is an FDA 510(k) clearance for the ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel, a Gram-negative Bacteria And Associated Resistance Markers (Class II — Special Controls, product code PEN), submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on April 12, 2019, 200 days after receiving the submission on September 24, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K182619 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2018
Decision Date	April 12, 2019
Days to Decision	200 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.