Cleared Traditional

K251092 - iHealth Flu A&B/COVID-19 Rapid Test

Also marketed or referenced as:
iHealth Flu A&B/COVID-19 Rapid Test Pro

K251092 is an FDA 510(k) clearance for iHealth Flu A&B/COVID-19 Rapid Test, manufactured by Ihealth Labs, Inc.. The device is a Class 2 Microbiology device with product code SCA cleared through the Traditional 510(k) pathway after a 246-day FDA review.

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

FDA 510(k) Submission Details - K251092

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.

SCA Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (SCA) and FDA review panel - the closest regulatory comparables to K251092.
Flowflex Plus RSV + Flu A/B + COVID Rapid Test
K261212 · ACON Laboratories, Inc. · Jul 2026
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