Cleared Special

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

K210385 · Roche Molecular Systems, Inc. · Microbiology

Sep 2021

Decision

212d

Days

Class 2

Risk

About This 510(k) Submission

K210385 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 9, 2021, 212 days after receiving the submission on February 9, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K210385 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 2021
Decision Date	September 09, 2021
Days to Decision	212 days
Submission Type	Special
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.