Cleared Traditional

K180255 - CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (FDA 510(k) Clearance)

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

K180255 · Hangzhou Clongene Biotech Co., Ltd. · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 2018
Decision
29d
Days
Class 2
Risk

K180255 is an FDA 510(k) clearance for the CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup. Classified as Test, Barbiturate, Over The Counter (product code PTH), Class II - Special Controls.

Submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 28, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 K180255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2018
Decision Date February 28, 2018
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 87d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PTH Test, Barbiturate, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
Definition The Barbiturate Test Is An In Vitro Diagnostic Test For The Qualitative Analysis Of Barbiturates In Human Urine.
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.