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510(k) K241915

CareSuperb™ COVID-19 Antigen Home Test by Access Bio, Inc. — Product Code QYT

K241915 is an FDA 510(k) premarket notification submitted by Access Bio, Inc. for the device "CareSuperb™ COVID-19 Antigen Home Test". The FDA issued a decision of Substantially Equivalent on January 29, 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. Access Bio, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2025
Date Received
July 1, 2024
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 Access Bio, Inc.

  • K251604 — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test (August 22, 2025)
  • K191514 — CareStart Flu A&B Plus (February 18, 2020)

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)
  • 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)
  • 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