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510(k) K231795

QuickVue COVID-19 Test by Quidel Corporation — Product Code QYT

K231795 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "QuickVue COVID-19 Test". The FDA issued a decision of Substantially Equivalent on March 22, 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. Quidel Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2024
Date Received
June 20, 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 Quidel Corporation

  • K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (December 20, 2023)
  • K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (December 13, 2023)
  • K230349 — Lyra RSV+hMPV Assay (March 10, 2023)
  • DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (March 8, 2023)
  • K230236 — Lyra Influenza A+B Assay (March 3, 2023)
  • K211342 — Sofia 2 Campylobacter FIA (November 23, 2021)
  • K173496 — Sofia 2 Lyme FIA, Sofia Lyme Control Set (August 30, 2018)
  • K181029 — Solana Bordetella Complete Assay (July 15, 2018)
  • K173691 — Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (February 28, 2018)
  • K180288 — QuickVue Influenza A+B (February 13, 2018)

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