Cleared Traditional

Flowflex COVID-19 Antigen Home Test

K230828 · ACON Laboratories, Inc. · Microbiology

Nov 2023

Decision

227d

Days

Class 2

Risk

About This 510(k) Submission

K230828 is an FDA 510(k) clearance for the Flowflex COVID-19 Antigen Home Test, a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on November 9, 2023, 227 days after receiving the submission on March 27, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K230828 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 2023
Decision Date	November 09, 2023
Days to Decision	227 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	QYT — Over-the-counter Covid-19 Antigen Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3984
Definition	For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older.