Cleared Traditional

K251753 - GenaCheck COVID-19 Rapid Self-Test (FDA 510(k) Clearance)

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

K251753 · Genabio Diagnostics, Inc. · Microbiology device
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Sep 2025
Decision
88d
Days
Class 2
Risk

K251753 is an FDA 510(k) clearance for the GenaCheck COVID-19 Rapid Self-Test. Classified as Over-the-counter Covid-19 Antigen Test (product code QYT), Class II - Special Controls.

Submitted by Genabio Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on September 5, 2025 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Genabio Diagnostics, Inc. devices

Submission Details

510(k) Number K251753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2025
Decision Date September 05, 2025
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
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 K251753.
Heal-Check Rapid COVID-19 Antigen Self-Test
K260095 · Healgen Scientific, LLC · Apr 2026
GenBody COVID-19 Ag Home Test
K251916 · Genbody.Inc. · Mar 2026
COVID-19 Detect Rapid Self -Test
K251595 · InBios International, Inc. · Oct 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