Cleared Traditional

iHealth COVID-19 Antigen Rapid Test (K233842) - FDA 510(k) Clearance

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

K233842 · Ihealth Labs, Inc. · Microbiology device
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May 2024
Decision
179d
Days
Class 2
Risk

K233842 is an FDA 510(k) clearance for the iHealth COVID-19 Antigen Rapid Test. Classified as Over-the-counter Covid-19 Antigen Test (product code QYT), Class II - Special Controls.

Submitted by Ihealth Labs, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 31, 2024 after a review of 179 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3984 - 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 K233842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2023
Decision Date May 31, 2024
Days to Decision 179 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
77d slower than avg
Panel avg: 102d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QYT Over-the-counter Covid-19 Antigen Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3984
Definition For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older.
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 - QYT Over-the-counter Covid-19 Antigen Test

All 13
Devices cleared under the same product code (QYT) and FDA review panel - the closest regulatory comparables to K233842.
CareSuperb™ COVID-19 Antigen Home Test
K241915 · Access Bio, Inc. · Jan 2025
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
K241317 · Guangzhou Wondfo Biotech Co., Ltd. · Sep 2024
CorDx Tyfast COVID-19 Ag Rapid Test
K240728 · CorDx, Inc. · Jun 2024
Flowflex® Plus COVID-19 Home Test
K233373 · ACON Laboratories, Inc. · Apr 2024
QuickVue COVID-19 Test
K231795 · Quidel Corporation · Mar 2024
Flowflex COVID-19 Antigen Home Test
K230828 · ACON Laboratories, Inc. · Nov 2023