Cleared Traditional

Flowflex? Plus COVID-19 Home Test

K233373 · ACON Laboratories, Inc. · Microbiology

Apr 2024

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K233373 is an FDA 510(k) clearance for the Flowflex? Plus COVID-19 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 April 19, 2024, 200 days after receiving the submission on October 2, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K233373 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2023
Decision Date	April 19, 2024
Days to Decision	200 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.