Cleared Traditional

K150179 - CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids (FDA 510(k) Clearance)

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

K150179 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
29d
Days
Class 2
Risk

K150179 is an FDA 510(k) clearance for the CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 25, 2015 after a review of 29 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 Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K150179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2015
Decision Date February 25, 2015
Days to Decision 29 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
58d faster than avg
Panel avg: 87d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
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 - DJG Enzyme Immunoassay, Opiates

All 214
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K150179.
Labcorp Fentanyl Urine Visual Test
K252684 · Medtox Diagnostics, Inc. · Jan 2026
Evidence MultiSTAT DOA Urine MultiPlex
K250741 · Randox Laboratories Limited · Jan 2026
LZI Buprenorphine II Enzyme Immunoassay
K253082 · Lin-Zhi International, Inc. · Jan 2026
SEFRIA™ Hydrocodone Oral Fluid
K252520 · Immunalysis Corporation · Sep 2025
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative
K251972 · Healgen Scientific, LLC · Aug 2025
LZI Fentanyl III Enzyme Immunoassay
K251634 · Lin-Zhi International, Inc. · Jun 2025