Cleared Traditional

cobas CTNG for use on cobas 6800/8800 systems

K202408 · Roche Molecular Systems, Inc. · Microbiology

Jan 2021

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K202408 is an FDA 510(k) clearance for the cobas CTNG for use on cobas 6800/8800 systems, a Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (Class II — Special Controls, product code QEP), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 21, 2021, 153 days after receiving the submission on August 21, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3393.

Submission Details

510(k) Number	K202408 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2020
Decision Date	January 21, 2021
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QEP — Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3393
Definition	A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data.