Cleared Traditional

QUANTA Flash Calprotectin and Fecal Extraction Device

K180971 · Inova Diagnostics, Inc. · Immunology

Oct 2018

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K180971 is an FDA 510(k) clearance for the QUANTA Flash Calprotectin and Fecal Extraction Device, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 16, 2018, 186 days after receiving the submission on April 13, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K180971 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2018
Decision Date	October 16, 2018
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	NXO — Calprotectin, Fecal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5180
Definition	The Device Is Used For The Measurement, In Human Stool, Of Fecal Calprotectin, A Neutrophilic Protein That Is A Marker Of Mucosal Inflammation. The Device Can Be Used As An Aid In The Diagnosis Of Inflammatory Bowel Disease (ibd), Crohn's Disease And Ulcerative Colitis And To Differentiate Ibd From Irritable Bowel Syndrome.