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510(k) K251595

COVID-19 Detect Rapid Self -Test by InBios International, Inc. — Product Code QYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2025
Date Received
May 27, 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 InBios International, Inc.

  • K233358 — SCoV-2 Ag Detect Rapid Test (August 23, 2024)
  • DEN220044 — Active Anthrax DetectTM Plus Rapid Test (February 3, 2023)
  • DEN180069 — ZIKV Detect 2.0 IgM Capture ELISA (May 23, 2019)
  • K181473 — DENV Detect NS1 ELISA (August 27, 2018)
  • K161947 — Chagas Detect Plus Rapid Test (December 16, 2016)
  • K141341 — CL DETECT RAPID TEST (November 14, 2014)

Other clearances for product code QYT

  • K251916 — GenBody COVID-19 Ag Home Test (March 13, 2026)
  • K251753 — GenaCheck COVID-19 Rapid Self-Test (September 5, 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)
  • K233373 — Flowflex® Plus COVID-19 Home Test (April 19, 2024)
  • K231795 — QuickVue COVID-19 Test (March 22, 2024)