Cleared Dual Track

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

K223783 · Roche Molecular Systems, Inc. · Microbiology
Dec 2023
Decision
353d
Days
Class 2
Risk

About This 510(k) Submission

K223783 is an FDA 510(k) clearance for the cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System, a Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings (Class II — Special Controls, product code QWR), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 4, 2023, 353 days after receiving the submission on December 16, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3982.

Submission Details

510(k) Number K223783 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2022
Decision Date December 04, 2023
Days to Decision 353 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QWR — Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3982
Definition A Simple Point-of-care Device To Detect Sars-cov-2 Nucleic Acid Targets Directly From Clinical Specimens In Near-patient Settings Is An In Vitro Diagnostic Device For The Direct Detection Of Sars-cov-2 In Clinical Specimens And Is Intended As An Aid In The Diagnosis Of Sars-cov-2 Infections (covid-19). The Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Design And Procedures Of The Device Are Appropriate For Use By Healthcare Professionals In Near-patient Settings Outside A Centralized Laboratory.