Cleared Traditional

K260095 - Heal-Check Rapid COVID-19 Antigen Self-Test (FDA 510(k) Clearance)

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

K260095 · Healgen Scientific, LLC · Microbiology device
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Apr 2026
Decision
90d
Days
Class 2
Risk

K260095 is an FDA 510(k) clearance for the Heal-Check Rapid COVID-19 Antigen Self-Test. Classified as Over-the-counter Covid-19 Antigen Test (product code QYT), Class II - Special Controls.

Submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on April 13, 2026 after a review of 90 days - within the typical 510(k) review window.

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 Healgen Scientific, LLC devices

Submission Details

510(k) Number K260095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2026
Decision Date April 13, 2026
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
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 12
Devices cleared under the same product code (QYT) and FDA review panel - the closest regulatory comparables to K260095.
GenBody COVID-19 Ag Home Test
K251916 · Genbody.Inc. · Mar 2026
COVID-19 Detect Rapid Self -Test
K251595 · InBios International, Inc. · Oct 2025
GenaCheck COVID-19 Rapid Self-Test
K251753 · Genabio Diagnostics, Inc. · Sep 2025
OHC COVID-19 Antigen Self Test
K241313 · Osang, LLC · May 2025
BinaxNOW™ COVID-19 Antigen Self Test
K243518 · Abbott Diagnostics Scarborough, Inc. · Feb 2025
CareSuperb™ COVID-19 Antigen Home Test
K241915 · Access Bio, Inc. · Jan 2025