Cleared Traditional

K231795 - QuickVue COVID-19 Test

K231795 is the FDA 510(k) clearance for QuickVue COVID-19 Test by Quidel Corporation. It is a Class 2 Microbiology device (product code QYT) cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K231795 · Quidel Corporation · Microbiology device
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Mar 2024
Decision
276d
Days
Class 2
Risk

K231795 is an FDA 510(k) clearance for the QuickVue COVID-19 Test. Classified as Over-the-counter Covid-19 Antigen Test (product code QYT), Class II - Special Controls.

Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on March 22, 2024 after a review of 276 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3984 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quidel Corporation devices

Submission Details

510(k) Number K231795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 102d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QYT Over-the-counter Covid-19 Antigen Test
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - QYT Over-the-counter Covid-19 Antigen Test

All 13
Devices cleared under the same product code (QYT) and FDA review panel - the closest regulatory comparables to K231795.
CorDx Tyfast COVID-19 Ag Rapid Test
K240728 · CorDx, Inc. · Jun 2024
iHealth COVID-19 Antigen Rapid Test
K233842 · Ihealth Labs, Inc. · May 2024
Flowflex® Plus COVID-19 Home Test
K233373 · ACON Laboratories, Inc. · Apr 2024
Flowflex COVID-19 Antigen Home Test
K230828 · ACON Laboratories, Inc. · Nov 2023