Cleared Traditional

COVID-19 Detect Rapid Self -Test

K251595 · InBios International, Inc. · Microbiology

Oct 2025

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K251595 is an FDA 510(k) clearance for the COVID-19 Detect Rapid Self -Test, a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by InBios International, Inc. (Seattle, US). The FDA issued a Cleared decision on October 12, 2025, 138 days after receiving the submission on May 27, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K251595 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2025
Decision Date	October 12, 2025
Days to Decision	138 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.