Cleared Special

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

K212427 · Roche Molecular Systems, Inc. · Microbiology

Oct 2021

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K212427 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 October 20, 2021, 77 days after receiving the submission on August 4, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K212427 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2021
Decision Date	October 20, 2021
Days to Decision	77 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.