Cleared Traditional

iC-GN iC-Cassette for use on the iC-System

K190341 · Icubate, Inc. · Microbiology

Jun 2019

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K190341 is an FDA 510(k) clearance for the iC-GN iC-Cassette for use on the iC-System, a Gram-negative Bacteria And Associated Resistance Markers (Class II — Special Controls, product code PEN), submitted by Icubate, Inc. (Huntsville, US). The FDA issued a Cleared decision on June 28, 2019, 134 days after receiving the submission on February 14, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K190341 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2019
Decision Date	June 28, 2019
Days to Decision	134 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.