Cleared Traditional

K131652 - LZI ORAL FLUID METHAMPHETAMINE ENZYME I...

K131652 is the FDA 510(k) clearance for LZI ORAL FLUID METHAMPHETAMINE ENZYME I... by Lin-Zhi International, Inc.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K131652 · Lin-Zhi International, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Mar 2014
Decision
289d
Days
Class 2
Risk

K131652 is an FDA 510(k) clearance for the LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 21, 2014 after a review of 289 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K131652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2013
Decision Date March 21, 2014
Days to Decision 289 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
202d slower than avg
Panel avg: 87d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 28
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K131652.
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LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
K113661 · Lin-Zhi International, Inc. · Jan 2012
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
K101753 · Microgenics Corp. · Apr 2011
ROCHE FLUDI METHAMPHETAMINE
K093884 · Roche Diagnostics · Feb 2011