Cleared Traditional

iC-GPC Assay TM for use on the iC-SystemTM

K163390 · Icubate, Inc. · Microbiology

Aug 2017

Decision

249d

Days

Class 2

Risk

About This 510(k) Submission

K163390 is an FDA 510(k) clearance for the iC-GPC Assay TM for use on the iC-SystemTM, a Gram-positive Bacteria And Their Resistance Markers (Class II — Special Controls, product code PAM), submitted by Icubate, Inc. (Huntsville, US). The FDA issued a Cleared decision on August 8, 2017, 249 days after receiving the submission on December 2, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K163390 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2016
Decision Date	August 08, 2017
Days to Decision	249 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.