Cleared Traditional

cobas? SARS-CoV-2 Qualitative for use on the cobas? 5800/6800/8800 Systems

K240867 · Roche Molecular Systems, Inc. · Microbiology

Feb 2025

Decision

319d

Days

Class 2

Risk

About This 510(k) Submission

K240867 is an FDA 510(k) clearance for the cobas? SARS-CoV-2 Qualitative for use on the cobas? 5800/6800/8800 Systems, a Respiratory Specimen Nucleic Acid Sars-cov-2 Test (Class II — Special Controls, product code QQX), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 11, 2025, 319 days after receiving the submission on March 29, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3981.

Submission Details

510(k) Number	K240867 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2024
Decision Date	February 11, 2025
Days to Decision	319 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QQX — Respiratory Specimen Nucleic Acid Sars-cov-2 Test
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 Sars-cov-2 That Cause Covid-19 Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 Nucleic Acid Targets In Human Clinical Respiratory Specimens From Patients Suspected Of Covid-19 Based On Signs And Symptoms Of Respiratory Infections By Their Healthcare Providers. The Device Is Intended To Aid In The Diagnosis Of Covid-19 In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors.