Cleared Traditional

K110182 - CANNABINOIDS URINE TEST (FDA 510(k) Clearance)

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

K110182 · Guangzhou Wondfo Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
119d
Days
Class 2
Risk

K110182 is an FDA 510(k) clearance for the CANNABINOIDS URINE TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on May 20, 2011 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3870 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K110182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2011
Decision Date May 20, 2011
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 Chemistry devices follow this clearance model.

Regulatory Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 149
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K110182.
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
K232732 · Co-Innovation Biotech Co., Ltd. · Jan 2024
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
K232604 · Hangzhou Laihe Biotech Co., Ltd. · Jan 2024
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
K223162 · Healgen Scientific, LLC · Mar 2023
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
K151203 · Immunalysis Corporation · Jun 2015
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
K141320 · Lin-Zhi International, Inc. · May 2015