Cleared Traditional

Fastep COVID-19 Antigen Pen Home Test (K260754) - FDA 510(k) Clearance

Also marketed or referenced as:
Fastep COVID-19 Antigen Pen Test

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

K260754 · Assure Tech., LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
88d
Days
Class 2
Risk

K260754 is an FDA 510(k) clearance for the Fastep COVID-19 Antigen Pen Home Test. Classified as Over-the-counter Covid-19 Antigen Test (product code QYT), Class II - Special Controls.

Submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on June 5, 2026 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 Assure Tech., LLC devices

Submission Details

510(k) Number K260754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2026
Decision Date June 05, 2026
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 Consultant

LSI International, Inc.
Jenny Xia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K260754.
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
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