Cleared Traditional

K141406 - IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS

K141406 is an FDA 510(k) clearance for IMMUNALYSIS BUPRENORPHINE URINE ENZYME ..., manufactured by Immunalysis Corporation. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K141406 · Immunalysis Corporation · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
34d
Days
Class 2
Risk

K141406 is an FDA 510(k) clearance for the IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on July 1, 2014 after a review of 34 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 Immunalysis Corporation devices

FDA 510(k) Submission Details - K141406

510(k) Number K141406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2014
Decision Date July 01, 2014
Days to Decision 34 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
53d faster than avg
Panel avg: 87d · This submission: 34d
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 177
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K141406.
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K140748 · Co-Innovation Biotech Co., Ltd. · Aug 2014
LZI HYDROCODONE
K141055 · Lin-Zhi International, Inc. · Jun 2014
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
K140089 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2014
STATUS DS OXY
K130650 · Princeton BioMeditech Corp. · Feb 2014