Cleared Traditional

K120763 - LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNO...

K120763 is the FDA 510(k) clearance for LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNO... by Lin-Zhi International, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K120763 · Lin-Zhi International, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
80d
Days
Class 2
Risk

K120763 is an FDA 510(k) clearance for the LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 1, 2012 after a review of 80 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 Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K120763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2012
Decision Date June 01, 2012
Days to Decision 80 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
7d faster than avg
Panel avg: 87d · This submission: 80d
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 126
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K120763.
LZI HYDROCODONE
K141055 · Lin-Zhi International, Inc. · Jun 2014
STATUS DS OXY
K130650 · Princeton BioMeditech Corp. · Feb 2014
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · Immunalysis Corporation · Jan 2014
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
K120761 · Lin-Zhi International, Inc. · May 2012
OPIATE ENZYME IMMUNOASSAY
K110298 · Lin-Zhi International, Inc. · Jul 2011
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
K101754 · Microgenics Corp. · Apr 2011