Cleared Traditional

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer

K170993 · Inova Diagnostics, Inc. · Immunology

Dec 2017

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K170993 is an FDA 510(k) clearance for the QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer, 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 December 22, 2017, 263 days after receiving the submission on April 3, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K170993 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2017
Decision Date	December 22, 2017
Days to Decision	263 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.