Cleared Traditional

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

K251092 · Ihealth Labs, Inc. · Microbiology

Dec 2025

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K251092 is an FDA 510(k) clearance for the iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro, a Multi-analyte Respiratory Virus Antigen Detection Test (Class II — Special Controls, product code SCA), submitted by Ihealth Labs, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 12, 2025, 246 days after receiving the submission on April 10, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3987.

Submission Details

510(k) Number	K251092 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2025
Decision Date	December 12, 2025
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	SCA — Multi-analyte Respiratory Virus Antigen Detection Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3987
Definition	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.