Cleared Traditional

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems

K243455 · Roche Molecular Systems, Inc. · Microbiology

Jul 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K243455 is an FDA 510(k) clearance for the cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems, a Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents (Class II — Special Controls, product code QOF), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on July 31, 2025, 266 days after receiving the submission on November 7, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3981.

Submission Details

510(k) Number	K243455 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2024
Decision Date	July 31, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QOF — Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3981
Definition	A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The Sars-cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-target Test Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 And Other Microbial Agents When In A Multi-target Test In Human Clinical Respiratory Specimens From Patients Suspected Of Respiratory Infection Who Are At Risk For Exposure Or Who May Have Been Exposed To These Agents. The Device Is Intended To Aid In The Diagnosis Of Respiratory Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors.