Cleared Traditional

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

K181663 · Genmark Diagnostics, Incorporated · Microbiology

Dec 2018

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K181663 is an FDA 510(k) clearance for the ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel, a Gram-positive Bacteria And Their Resistance Markers (Class II — Special Controls, product code PAM), submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on December 20, 2018, 178 days after receiving the submission on June 25, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K181663 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2018
Decision Date	December 20, 2018
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PAM — Gram-positive Bacteria And Their Resistance Markers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3365
Definition	A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures.