Cleared Traditional

K240949 - Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) (FDA 510(k) Clearance)

Also includes:
Healgen® Accurate Rapid Fentanyl Test Cassette (Urine) Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine) Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine) Healgen® Accurate Fentanyl Rapid Test Strip (Urine) Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

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

K240949 · Healgen Scientific, LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
35d
Days
Class 2
Risk

K240949 is an FDA 510(k) clearance for the Healgen® Accurate Fentanyl Rapid Test Cassette (Urine). 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 May 13, 2024 after a review of 35 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 K240949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2024
Decision Date May 13, 2024
Days to Decision 35 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
52d faster than avg
Panel avg: 87d · This submission: 35d
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.
Joe Shia

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 K240949.
Healgen Accurate Urine Drug Screen Dip Card
K253567 · Healgen Scientific, LLC · Dec 2025
Deepblue Multi-Drug Urine Test Cup
K250803 · Anhui Deepblue Medical Technological Co., Ltd. · Apr 2025
Dochek® Multi-Drug Urine Test Cup
K250067 · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 2025
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
K242428 · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 2025
Healgen Accurate Muti-Drug Urine Drug Screen Cup
K243365 · Healgen Scientific, LLC · Dec 2024
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold)
K243064 · Eterbio, Inc. · Nov 2024