Cleared Special

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

K231306 · Roche Molecular Systems, Inc. · Microbiology

Jun 2023

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K231306 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 June 1, 2023, 27 days after receiving the submission on May 5, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3981.

Submission Details

510(k) Number	K231306 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2023
Decision Date	June 01, 2023
Days to Decision	27 days
Submission Type	Special
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.