Cleared Traditional

Flowflex Plus COVID-19 + Flu A/B Home Test

K250377 · ACON Laboratories, Inc. · Microbiology

May 2025

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K250377 is an FDA 510(k) clearance for the Flowflex Plus COVID-19 + Flu A/B Home Test, a Multi-analyte Respiratory Virus Antigen Detection Test (Class II — Special Controls, product code SCA), submitted by ACON Laboratories, Inc. (Diego, US). The FDA issued a Cleared decision on May 10, 2025, 89 days after receiving the submission on February 10, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3987.

Submission Details

510(k) Number	K250377 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 2025
Decision Date	May 10, 2025
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

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.