Cleared Traditional

cobas Cdiff Nucleic acid test for use on the cobas Liat System

K171770 · Roche Molecular Systems, Inc. · Microbiology

Sep 2017

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K171770 is an FDA 510(k) clearance for the cobas Cdiff Nucleic acid test for use on the cobas Liat System, a C. Difficile Toxin Gene Amplification Assay (Class II — Special Controls, product code OZN), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on September 12, 2017, 90 days after receiving the submission on June 14, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K171770 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2017
Decision Date	September 12, 2017
Days to Decision	90 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.