Cleared Traditional

K241317 - Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241317 · Guangzhou Wondfo Biotech Co., Ltd. · Microbiology device
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Sep 2024
Decision
143d
Days
Class 2
Risk

K241317 is an FDA 510(k) clearance for the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method). Classified as Over-the-counter Covid-19 Antigen Test (product code QYT), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on September 30, 2024 after a review of 143 days - within the typical 510(k) review window.

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 Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K241317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2024
Decision Date September 30, 2024
Days to Decision 143 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
41d slower than avg
Panel avg: 102d · This submission: 143d
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 12
Devices cleared under the same product code (QYT) and FDA review panel - the closest regulatory comparables to K241317.
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