Cleared Traditional

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel (K241969) - FDA 510(k) Clearance

Also marketed or referenced as:
Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

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

K241969 · Qingdao Hightop Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
40d
Days
Class 2
Risk

K241969 is an FDA 510(k) clearance for the Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel. Classified as Test, Opiates, Over The Counter (product code NGL), Class II - Special Controls.

Submitted by Qingdao Hightop Biotech Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on August 14, 2024 after a review of 40 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 Qingdao Hightop Biotech Co., Ltd. devices

Submission Details

510(k) Number K241969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2024
Decision Date August 14, 2024
Days to Decision 40 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
47d faster than avg
Panel avg: 87d · This submission: 40d
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 20
Devices cleared under the same product code (NGL) and FDA review panel - the closest regulatory comparables to K241969.
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold)
K243064 · Eterbio, Inc. · Nov 2024
CLUNGENE Fentanyl Home Test Cassette
K242802 · Hangzhou Clongene Biotech Co., Ltd. · Nov 2024
BioSieve™ Fentanyl FIA Home Test Kit
K241869 · Vivachek Biotech (Hangzhou) Co., Ltd. · Oct 2024
SAFElife™ Fentanyl Urine Home Test (Cassette)
K241741 · Guangzhou Wondfo Biotech Co., Ltd. · Jul 2024
Rapid Urine Fentanyl (FYL) Test Strip
K241100 · Co-Innovation Biotech Co., Ltd. · May 2024
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine)
K240949 · Healgen Scientific, LLC · May 2024