Cleared Traditional

K232736 - Chemtrue Drug Screen Fentanyl/Tramadol ...

K232736 is an FDA 510(k) clearance for Chemtrue Drug Screen Fentanyl/Tramadol ..., manufactured by Chemtron Biotech, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K232736 · Chemtron Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
104d
Days
Class 2
Risk

K232736 is an FDA 510(k) clearance for the Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fenta.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Chemtron Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 20, 2023 after a review of 104 days - within the typical 510(k) review window.

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

View all Chemtron Biotech, Inc. devices

FDA 510(k) Submission Details - K232736

510(k) Number K232736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2023
Decision Date December 20, 2023
Days to Decision 104 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
17d slower than avg
Panel avg: 87d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

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 Peers - DJG Enzyme Immunoassay, Opiates

All 149
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K232736.
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
K231904 · Co-Innovation Biotech Co., Ltd. · Mar 2024
Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
K232228 · Shanghai Accurature Diagnostics Co., Ltd. · Feb 2024
LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
K232597 · Hangzhou Laihe Biotech Co., Ltd. · Jan 2024
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
K232659 · Guangzhou Decheng Biotechnology Co., Ltd. · Dec 2023
ARK Hydrocodone Assay
K231752 · ARK Diagnostics, Inc. · Nov 2023
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
K220451 · Randox Laboratories Limited · Oct 2023