Cleared Traditional

K242802 - CLUNGENE Fentanyl Home Test Cassette (FDA 510(k) Clearance)

Also includes:
CLUNGENE Fentanyl Test Cassette

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

K242802 · Hangzhou Clongene Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
52d
Days
Class 2
Risk

K242802 is an FDA 510(k) clearance for the CLUNGENE Fentanyl Home Test Cassette. Classified as Test, Opiates, Over The Counter (product code NGL), Class II - Special Controls.

Submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on November 8, 2024 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hangzhou Clongene Biotech Co., Ltd. devices

Submission Details

510(k) Number K242802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2024
Decision Date November 08, 2024
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 87d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGL Test, Opiates, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 Toxicology devices follow this clearance model.

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.

Regulatory Peers - NGL Test, Opiates, Over The Counter

All 22
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