Cleared Traditional

Healgen Rapid COVID-19 Antigen Test

K232377 · Healgen Scientific, LLC · Microbiology

Apr 2024

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K232377 is an FDA 510(k) clearance for the Healgen Rapid COVID-19 Antigen Test, 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 Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on April 19, 2024, 255 days after receiving the submission on August 8, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3982.

Submission Details

510(k) Number	K232377 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2023
Decision Date	April 19, 2024
Days to Decision	255 days
Submission Type	Traditional
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