iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro

Q: What is the product code of K251085?

The FDA product code is SCA – Multi-Analyte Respiratory Virus Antigen Detection Test, a Class II (moderate risk) device regulated under 21 CFR 866.3987.

FDA 510(k) K251085 · Ihealth Labs, Inc.

Substantially Equivalent

510(k) numberK251085

Submission

Device name: iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
Applicant: Ihealth Labs, Inc.
Sunnyvale, CA, US
Received: April 9, 2025
Decision date: December 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: SCA – Multi-Analyte Respiratory Virus Antigen Detection Test
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3987
Specialty: Microbiology

A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.

Other 510(k)s with product code SCA

510(k)	Device	Applicant	Decision
K261212	Flowflex Plus RSV + Flu A/B + COVID Rapid TestSCA · Dual Track	ACON Laboratories, Inc.	07/10/2026SE
K251092	iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProSCA · Traditional	Ihealth Labs, Inc.	12/12/2025SE
K251538	Status COVID-19/Flu A&BSCA · Dual Track	Princeton BioMeditech Corp.	11/14/2025SE
K251749	Flowflex Plus RSV + Flu A/B + COVID Home TestSCA · Traditional	ACON Laboratories, Inc.	10/22/2025SE
K251604	CareSuperb COVID-19/Flu A&B Antigen Combo Home TestSCA · Traditional	Access Bio, Inc.	08/22/2025SE
K251563	WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestSCA · Traditional	Wondfo USA Co, Ltd.	08/20/2025SE
K243561	Nano-Check Influenza+COVID-19 Dual TestSCA · Dual Track	Nano-Ditech Corporation	06/17/2025SE
K250377	Flowflex Plus COVID-19 + Flu A/B Home TestSCA · Traditional	ACON Laboratories, Inc.	05/10/2025SE
K243256	WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B…SCA · Traditional	Wondfo USA Co, Ltd.	01/16/2025SE
K243262	QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro TestSCA · Traditional	Osang, LLC	01/13/2025SE

More from Osang, LLC

510(k)	Device	Decision
K251092	iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProSCA · Traditional	12/12/2025SE
K243146	iCare APPMWI · Traditional	02/03/2025SE
K233842	iHealth COVID-19 Antigen Rapid TestQYT · Traditional	05/31/2024SE

Questions and answers

When was iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro cleared by the FDA?

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (K251085) received a 510(k) decision of Substantially Equivalent on December 12, 2025, 247 days after the submission was received.

What is the product code of K251085?

The FDA product code is SCA – Multi-Analyte Respiratory Virus Antigen Detection Test, a Class II (moderate risk) device regulated under 21 CFR 866.3987.