Cleared Traditional

QuickVue COVID-19 Test

K231795 · Quidel Corporation · Microbiology

Mar 2024

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K231795 is an FDA 510(k) clearance for the QuickVue COVID-19 Test, a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on March 22, 2024, 276 days after receiving the submission on June 20, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K231795 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2023
Decision Date	March 22, 2024
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QYT — Over-the-counter Covid-19 Antigen Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3984
Definition	For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older.