Cleared Traditional

K241317 - Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

K241317 is an FDA 510(k) clearance for Wondfo 2019-nCoV Antigen Test (Lateral ..., manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The device is a Class 2 Microbiology device with product code QYT cleared through the Traditional 510(k) pathway after a 143-day FDA review.

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

FDA 510(k) Submission Details - K241317

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.

QYT Device Classification - Class 2, Special Controls

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
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