Cleared Traditional

WELLlife? COVID-19 / Influenza A&B Home Test; WELLlife? COVID-19 / Influenza A&B AntigenTest

K243256 · Wondfo USA Co., Ltd. · Microbiology

Jan 2025

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K243256 is an FDA 510(k) clearance for the WELLlife? COVID-19 / Influenza A&B Home Test; WELLlife? COVID-19 / Influenza A&B AntigenTest, a Multi-analyte Respiratory Virus Antigen Detection Test (Class II — Special Controls, product code SCA), submitted by Wondfo USA Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on January 16, 2025, 93 days after receiving the submission on October 15, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3987.

Submission Details

510(k) Number	K243256 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2024
Decision Date	January 16, 2025
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	SCA — Multi-analyte Respiratory Virus Antigen Detection Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3987
Definition	A Multi-analyte Respiratory Virus Antigen Detection Test Is An In Vitro Diagnostic Device Intended For The Detection And/or Differentiation Of Respiratory Viruses Directly From Respiratory Clinical Specimens. The Device Is Intended To Be Performed At The Site Of Sample Collection, Does Not Involve Sample Storage And/or Transport.