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510(k) K251595

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

K251595 is an FDA 510(k) premarket notification submitted by InBios International, Inc. for the device "COVID-19 Detect Rapid Self -Test". The FDA issued a decision of Substantially Equivalent on October 12, 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. InBios International, Inc. has at least 6 other 510(k) clearances on record.

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

  • 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)
  • 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)

FDA data resources