Cleared Traditional

GenePOC CDiff

K172569 · Genepoc, Inc. · Microbiology

Nov 2017

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K172569 is an FDA 510(k) clearance for the GenePOC CDiff, a C. Difficile Toxin Gene Amplification Assay (Class II — Special Controls, product code OZN), submitted by Genepoc, Inc. (Quebec, CA). The FDA issued a Cleared decision on November 22, 2017, 89 days after receiving the submission on August 25, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K172569 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2017
Decision Date	November 22, 2017
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZN — C. Difficile Toxin Gene Amplification Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3130
Definition	Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.