COVID-19 Detect Rapid Self -Test

Q: What is the product code of K251595?

The FDA product code is QYT – Over-The-Counter Covid-19 Antigen Test, a Class II (moderate risk) device regulated under 21 CFR 866.3984.

FDA 510(k) K251595 · InBios International, Inc.

Substantially Equivalent

510(k) numberK251595

Submission

Device name: COVID-19 Detect Rapid Self -Test
Applicant: InBios International, Inc.
Seattle, WA, US
Received: May 27, 2025
Decision date: October 12, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QYT – Over-The-Counter Covid-19 Antigen Test
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3984
Specialty: Microbiology

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

Other 510(k)s with product code QYT

510(k)	Device	Applicant	Decision
K260754	Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT · Traditional	Assure Tech., LLC	06/05/2026SE
K260095	Heal-Check Rapid COVID-19 Antigen Self-TestQYT · Traditional	Healgen Scientific,, LLC	04/13/2026SE
K251916	GenBody COVID-19 Ag Home TestQYT · Traditional	Genbody.Inc.	03/13/2026SE
K251753	GenaCheck COVID-19 Rapid Self-TestQYT · Traditional	Genabio Diagnostics, Inc.	09/05/2025SE
K241313	OHC COVID-19 Antigen Self TestQYT · Traditional	Osang, LLC	05/30/2025SE
K243518	BinaxNOW COVID-19 Antigen Self TestQYT · Traditional	Abbott Diagnostics Scarborough, Inc.	02/11/2025SE
K241915	CareSuperb COVID-19 Antigen Home TestQYT · Traditional	Access Bio, Inc.	01/29/2025SE
K241317	Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)QYT · Traditional	Guangzhou Wondfo Biotech Co., Ltd.	09/30/2024SE
K240728	CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestQYT · Traditional	CorDx, Inc.	06/21/2024SE
K233842	iHealth COVID-19 Antigen Rapid TestQYT · Traditional	Ihealth Labs, Inc.	05/31/2024SE

More from Ihealth Labs, Inc.

510(k)	Device	Decision
K233358	SCoV-2 Ag Detect Rapid TestQVF · Dual Track	08/23/2024SE
K181473	DENV Detect NS1 ELISAQCU · Traditional	08/27/2018SE
K161947	Chagas Detect Plus Rapid TestMIU · Traditional	12/16/2016SE
K141341	CL Detect Rapid TestPIT · Traditional	11/14/2014SE

Questions and answers

When was COVID-19 Detect Rapid Self -Test cleared by the FDA?

COVID-19 Detect Rapid Self -Test (K251595) received a 510(k) decision of Substantially Equivalent on October 12, 2025, 138 days after the submission was received.

What is the product code of K251595?

The FDA product code is QYT – Over-The-Counter Covid-19 Antigen Test, a Class II (moderate risk) device regulated under 21 CFR 866.3984.