iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
FDA 510(k) K251092 · Ihealth Labs, Inc.
510(k) numberK251092
Submission
- Device name
- iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
- Applicant
- Ihealth Labs, Inc.
Sunnyvale, CA, US - Received
- April 10, 2025
- Decision date
- December 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV 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 |
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Questions and answers
When was iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro cleared by the FDA?
iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (K251092) received a 510(k) decision of Substantially Equivalent on December 12, 2025, 246 days after the submission was received.
What is the product code of K251092?
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.