Cleared Traditional

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel

K182690 · Genmark Diagnostics, Incorporated · Microbiology
Dec 2018
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K182690 is an FDA 510(k) clearance for the ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel, a Fungal Organisms, Nucleic Acid-based Assay (Class II — Special Controls, product code PEO), submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on December 21, 2018, 85 days after receiving the submission on September 27, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number K182690 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2018
Decision Date December 21, 2018
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PEO — Fungal Organisms, Nucleic Acid-based Assay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3365
Definition A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Fungal Organisms In Positive Blood Cultures.