Cleared Dual Track

BD Veritor System for SARS-CoV-2

K243872 · Becton, Dickinson and Company · Microbiology

Jun 2025

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K243872 is an FDA 510(k) clearance for the BD Veritor System for SARS-CoV-2, a Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings (Class II — Special Controls, product code QVF), submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on June 16, 2025, 181 days after receiving the submission on December 17, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3982.

Submission Details

510(k) Number	K243872 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2024
Decision Date	June 16, 2025
Days to Decision	181 days
Submission Type	Dual Track
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QVF — Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral 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 Viral 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