Cleared Traditional

K243365 - Healgen Accurate Muti-Drug Urine Drug Screen Cup (FDA 510(k) Clearance)

Also includes:
Healgen Accurate Home Muti-Drug Urine Test Cup

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

K243365 · Healgen Scientific, LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
49d
Days
Class 2
Risk

K243365 is an FDA 510(k) clearance for the Healgen Accurate Muti-Drug Urine Drug Screen Cup. Classified as Test, Opiates, Over The Counter (product code NGL), Class II - Special Controls.

Submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on December 17, 2024 after a review of 49 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 Healgen Scientific, LLC devices

Submission Details

510(k) Number K243365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2024
Decision Date December 17, 2024
Days to Decision 49 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
38d faster than avg
Panel avg: 87d · This submission: 49d
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
Devices cleared under the same product code (NGL) and FDA review panel - the closest regulatory comparables to K243365.
Healgen Accurate Urine Drug Screen Dip Card
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