Cleared Traditional

K110239 - LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZ...

K110239 is the FDA 510(k) clearance for LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZ... by Lin-Zhi International, Inc.. It is a Class 2 Chemistry device (product code LDJ) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K110239 · Lin-Zhi International, Inc. · Chemistry device
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Jun 2011
Decision
148d
Days
Class 2
Risk

K110239 is an FDA 510(k) clearance for the LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 23, 2011 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3870 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K110239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2011
Decision Date June 23, 2011
Days to Decision 148 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
60d slower than avg
Panel avg: 88d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K110239.
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K092269 · Randox Laboratories, Ltd. · Apr 2011
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
K101744 · Microgenics Corp. · Apr 2011