Cleared Traditional

K253318 - Clungene RSV Antigen Rapid Test (FDA 510(k) Clearance)

Class I Microbiology device.

K253318 · Hangzhou Clongene Biotech Co., Ltd. · Microbiology device
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Jan 2026
Decision
122d
Days
Class 1
Risk

K253318 is an FDA 510(k) clearance for the Clungene RSV Antigen Rapid Test. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 30, 2026 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3480 - 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 Hangzhou Clongene Biotech Co., Ltd. devices

Submission Details

510(k) Number K253318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date January 30, 2026
Days to Decision 122 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
20d slower than avg
Panel avg: 102d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3480
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

LSI International, Inc.
Jenny Xia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.