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510(k) K251753

GenaCheck COVID-19 Rapid Self-Test by Genabio Diagnostics, Inc. — Product Code QYT

K251753 is an FDA 510(k) premarket notification submitted by Genabio Diagnostics, Inc. for the device "GenaCheck COVID-19 Rapid Self-Test". The FDA issued a decision of Substantially Equivalent on September 5, 2025. The device falls under product code QYT (Over-The-Counter Covid-19 Antigen Test), a Class II device regulated under 21 CFR 866.3984. Genabio Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2025
Date Received
June 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Covid-19 Antigen Test
Device Class
Class II
Regulation Number
866.3984
Review Panel
MI
Submission Type

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

Other clearances by Genabio Diagnostics, Inc.

  • K240545 — GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherap (August 28, 2024)

Other clearances for product code QYT

  • K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test (June 5, 2026)
  • K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test (April 13, 2026)
  • K251916 — GenBody COVID-19 Ag Home Test (March 13, 2026)
  • K251595 — COVID-19 Detect Rapid Self -Test (October 12, 2025)
  • K241313 — OHC COVID-19 Antigen Self Test (May 30, 2025)
  • K243518 — BinaxNOW™ COVID-19 Antigen Self Test (February 11, 2025)
  • K241915 — CareSuperb™ COVID-19 Antigen Home Test (January 29, 2025)
  • K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (September 30, 2024)
  • K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (June 21, 2024)
  • K233842 — iHealth COVID-19 Antigen Rapid Test (May 31, 2024)

FDA data resources