Cleared Traditional

K152025 - AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

K152025 is an FDA 510(k) clearance for AssureTech Buprenorphine Tests (Strip, manufactured by Assure Tech. Co., Ltd.. The device is a Class 2 Chemistry device with product code DJR cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K152025 · Assure Tech. Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
75d
Days
Class 2
Risk

K152025 is an FDA 510(k) clearance for the AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split C.... Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Assure Tech. Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 5, 2015 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3620 - 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: 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 Assure Tech. Co., Ltd. devices

FDA 510(k) Submission Details - K152025

510(k) Number K152025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2015
Decision Date October 05, 2015
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJR Device Classification - Class 2, Special Controls

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 Consultant

Lsi International
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 - DJR Enzyme Immunoassay, Methadone

All 57
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K152025.
ARK EDDP Assay
K182779 · ARK Diagnostics, Inc. · Nov 2018
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
K170416 · Lin-Zhi International, Inc. · Jun 2017
First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
K160793 · W.H.P.M., Inc. · Aug 2016
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K151395 · Immunalysis Corporation · Jul 2015
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
K151441 · W.H.P.M., Inc. · Jun 2015
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
K131232 · Guangzhou Wondfo Biotech Co., Ltd. · May 2013