Cleared Traditional

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test

K251563 · Wondfo USA Co., Ltd. · Microbiology

Aug 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K251563 is an FDA 510(k) clearance for the WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test, 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 August 20, 2025, 90 days after receiving the submission on May 22, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3987.

Submission Details

510(k) Number	K251563 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2025
Decision Date	August 20, 2025
Days to Decision	90 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.