Cleared Traditional

K251092 - iHealth Flu A&B/COVID-19 Rapid Test (FDA 510(k) Clearance)

Also includes:
iHealth Flu A&B/COVID-19 Rapid Test Pro

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251092 · Ihealth Labs, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
246d
Days
Class 2
Risk

K251092 is an FDA 510(k) clearance for the iHealth Flu A&B/COVID-19 Rapid Test. Classified as Multi-analyte Respiratory Virus Antigen Detection Test (product code SCA), Class II - Special Controls.

Submitted by Ihealth Labs, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 12, 2025 after a review of 246 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3987 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ihealth Labs, Inc. devices

Submission Details

510(k) Number K251092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 102d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SCA Multi-analyte Respiratory Virus Antigen Detection Test
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - SCA Multi-analyte Respiratory Virus Antigen Detection Test

All 10
Devices cleared under the same product code (SCA) and FDA review panel - the closest regulatory comparables to K251092.
iHealth Flu A&B/COVID-19/RSV Rapid Test
K251085 · Ihealth Labs, Inc. · Dec 2025
Status™ COVID-19/Flu A&B
K251538 · Princeton BioMeditech Corp. · Nov 2025
Flowflex Plus RSV + Flu A/B + COVID Home Test
K251749 · ACON Laboratories, Inc. · Oct 2025
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
K251604 · Access Bio, Inc. · Aug 2025
WELLlife Flu A&B Home Test
K251563 · Wondfo USA Co., Ltd. · Aug 2025
Nano-Check Influenza+COVID-19 Dual Test
K243561 · Nano-Ditech Corporation · Jun 2025