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510(k) K233373

Flowflex® Plus COVID-19 Home Test by ACON Laboratories, Inc. — Product Code QYT

K233373 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "Flowflex® Plus COVID-19 Home Test". The FDA issued a decision of Substantially Equivalent on April 19, 2024. The device falls under product code QYT (Over-The-Counter Covid-19 Antigen Test), a Class II device regulated under 21 CFR 866.3984. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2024
Date Received
October 2, 2023
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 ACON Laboratories, Inc.

  • K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test (July 10, 2026)
  • K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test St (November 26, 2025)
  • K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test (October 22, 2025)
  • K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK (October 10, 2025)
  • K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test (May 10, 2025)
  • K232715 — Distinct® Digital Pregnancy Test (May 31, 2024)
  • K230828 — Flowflex COVID-19 Antigen Home Test (November 9, 2023)
  • K193318 — Distinct® Early Detection Pregnancy Test (August 20, 2020)
  • K192175 — On Call Express II Blood Glucose Monitoring System (October 17, 2019)
  • K191038 — On Call Express Voice Blood Glucose Monitoring System (June 12, 2019)

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)
  • 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)

FDA data resources