Cleared Traditional

K192433 - LZI Methadone II Enzyme Immunoassay

K192433 is an FDA 510(k) clearance for LZI Methadone II Enzyme Immunoassay, manufactured by Lin-Zhi International, Inc.. The device is a Class 2 Toxicology device with product code DJR cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K192433 · Lin-Zhi International, Inc. · Toxicology device
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Oct 2019
Decision
29d
Days
Class 2
Risk

K192433 is an FDA 510(k) clearance for the LZI Methadone II Enzyme Immunoassay. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 4, 2019 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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 Lin-Zhi International, Inc. devices

FDA 510(k) Submission Details - K192433

510(k) Number K192433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2019
Decision Date October 04, 2019
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.

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 Toxicology devices follow this clearance model.

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 K192433.
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
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 · Assure Tech. Co., Ltd. · Oct 2015
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