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

FDA 510(k) K163390 · Icubate, Inc.

Substantially Equivalent

510(k) numberK163390

Submission

Device name
iC-GPC Assay TM for use on the iC-SystemTM
Applicant
Icubate, Inc.
Huntsville, AL, US
Received
December 2, 2016
Decision date
August 8, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PAM – Gram-Positive Bacteria And Their Resistance Markers
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3365
Specialty
Microbiology

A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.

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K243490LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional Luminex Corporation06/06/2025SE
K181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelPAM · Traditional Genmark Diagnostics, Incorporated12/20/2018SE
K152470Great Basin Staph ID/R Blood Culture PanelPAM · Traditional Great Basin Scientific, Inc.03/25/2016SE
K122514Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestPAM · Traditional Nanosphere, Inc.09/19/2012SE

More from Nanosphere, Inc.

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Questions and answers

When was iC-GPC Assay TM for use on the iC-SystemTM cleared by the FDA?

iC-GPC Assay TM for use on the iC-SystemTM (K163390) received a 510(k) decision of Substantially Equivalent on August 8, 2017, 249 days after the submission was received.

What is the product code of K163390?

The FDA product code is PAM – Gram-Positive Bacteria And Their Resistance Markers, a Class II (moderate risk) device regulated under 21 CFR 866.3365.