Cleared Traditional

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) (K243064) - FDA 510(k) Clearance

Also marketed or referenced as:
ETERBIO Fentanyl/Norfentanyl Home Test

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

K243064 · Eterbio, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
54d
Days
Class 2
Risk

K243064 is an FDA 510(k) clearance for the ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold). Classified as Test, Opiates, Over The Counter (product code NGL), Class II - Special Controls.

Submitted by Eterbio, Inc. (Zhuhai, CN). The FDA issued a Cleared decision on November 20, 2024 after a review of 54 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 Eterbio, Inc. devices

Submission Details

510(k) Number K243064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date November 20, 2024
Days to Decision 54 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 87d · This submission: 54d
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 K243064.
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
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
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel
K241969 · Qingdao Hightop Biotech Co., Ltd. · Aug 2024