Cleared Traditional

K260095 - Heal-Check Rapid COVID-19 Antigen Self-Test

K260095 is an FDA 510(k) clearance for Heal-Check Rapid COVID-19 Antigen Self-Test, manufactured by Healgen Scientific, LLC. The device is a Class 2 Microbiology device with product code QYT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K260095

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.

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 K260095.
Fastep COVID-19 Antigen Pen Home Test
K260754 · Assure Tech., LLC · Jun 2026
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