Cleared Traditional

K233842 - iHealth COVID-19 Antigen Rapid Test

K233842 is an FDA 510(k) clearance for iHealth COVID-19 Antigen Rapid Test, manufactured by Ihealth Labs, Inc.. The device is a Class 2 Microbiology device with product code QYT cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K233842 · Ihealth Labs, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K233842

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.

QYT Device Classification - Class 2, Special Controls

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