Cleared Traditional

Rapid Urine Fentanyl (FYL) Test Strip (K241100) - FDA 510(k) Clearance

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

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

K241100 · Co-Innovation Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
30d
Days
Class 2
Risk

K241100 is an FDA 510(k) clearance for the Rapid Urine Fentanyl (FYL) Test Strip. Classified as Test, Opiates, Over The Counter (product code NGL), Class II - Special Controls.

Submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 22, 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 Co-Innovation Biotech Co., Ltd. devices

Submission Details

510(k) Number K241100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2024
Decision Date May 22, 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 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 K241100.
BioSieve™ Fentanyl FIA Home Test Kit
K241869 · Vivachek Biotech (Hangzhou) Co., Ltd. · Oct 2024
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel
K241969 · Qingdao Hightop Biotech Co., Ltd. · Aug 2024
SAFElife™ Fentanyl Urine Home Test (Cassette)
K241741 · Guangzhou Wondfo Biotech Co., Ltd. · Jul 2024
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine)
K240949 · Healgen Scientific, LLC · May 2024
Healgen Accurate Urine Drug Screen Dip Card
K240686 · Healgen Scientific, LLC · Apr 2024
SAFECARE Fentanyl Urine Test Cassette
K240654 · Safecare Biotech (Hangzhou) Co., Ltd. · Apr 2024