Cleared Traditional

K232228 - Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card (FDA 510(k) Clearance)

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

K232228 · Shanghai Accurature Diagnostics Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
211d
Days
Class 2
Risk

K232228 is an FDA 510(k) clearance for the Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-d.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Shanghai Accurature Diagnostics Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 23, 2024 after a review of 211 days - an extended review 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: 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 Shanghai Accurature Diagnostics Co., Ltd. devices

Submission Details

510(k) Number K232228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2023
Decision Date February 23, 2024
Days to Decision 211 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
124d slower than avg
Panel avg: 87d · This submission: 211d
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 Peers - DJG Enzyme Immunoassay, Opiates

All 214
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K232228.
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