Cleared Traditional

FaStep Fentanyl Rapid Test Device (Urine) (K240351) - FDA 510(k) Clearance

Also marketed or referenced as:
FaStep Rapid Fentanyl Urine Test (Urine)

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

K240351 · Assure Tech., LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
30d
Days
Class 2
Risk

K240351 is an FDA 510(k) clearance for the FaStep Fentanyl Rapid Test Device (Urine). Classified as Test, Opiates, Over The Counter (product code NGL), Class II - Special Controls.

Submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on March 6, 2024 after a review of 30 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 Assure Tech., LLC devices

Submission Details

510(k) Number K240351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2024
Decision Date March 06, 2024
Days to Decision 30 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
57d faster than avg
Panel avg: 87d · This submission: 30d
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 20
Devices cleared under the same product code (NGL) and FDA review panel - the closest regulatory comparables to K240351.
SAFECARE Fentanyl Urine Test Cassette
K240654 · Safecare Biotech (Hangzhou) Co., Ltd. · Apr 2024
InstaStrip Fentanyl Rapid Test (Urine)
K240295 · Instanosis, Inc. · Mar 2024
AllSource Drug Detector FenTest
K234006 · Allsource Screening Solutions · Mar 2024
AllTest Fentanyl Urine Test Cassette
K233417 · Hangzhou AllTest Biotech Co., Ltd. · Oct 2023
BIOEASY Multi-Drug Test Cup
K193480 · Shenzhen Bioeasy Biotechnology Co., Ltd. · Jan 2020
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K190412 · Hangzhou Clongene Biotech Co., Ltd. · Mar 2019