Cleared Traditional

BinaxNOW? COVID-19 Antigen Self Test

K243518 · Abbott Diagnostics Scarborough, Inc. · Microbiology

Feb 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K243518 is an FDA 510(k) clearance for the BinaxNOW? COVID-19 Antigen Self Test, a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by Abbott Diagnostics Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on February 11, 2025, 90 days after receiving the submission on November 13, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K243518 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2024
Decision Date	February 11, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

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.