Cleared Dual Track

cobas liat SARS-CoV-2 v2 nucleic acid test

K243346 · Roche Molecular Systems, Inc. · Microbiology
Apr 2025
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K243346 is an FDA 510(k) clearance for the cobas liat SARS-CoV-2 v2 nucleic acid test, 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 April 11, 2025, 165 days after receiving the submission on October 28, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3982.

Submission Details

510(k) Number K243346 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2024
Decision Date April 11, 2025
Days to Decision 165 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.