Cleared Traditional

K040464 - AMEDICA DRUG SCREEN THC/COC

K040464 is the FDA 510(k) clearance for AMEDICA DRUG SCREEN THC/COC by Amedica Biotech, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K040464 · Amedica Biotech, Inc. · Toxicology device
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May 2004
Decision
84d
Days
Class 2
Risk

K040464 is an FDA 510(k) clearance for the AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Amedica Biotech, Inc. (Hayward, US). The FDA issued a Cleared decision on May 17, 2004 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 Amedica Biotech, Inc. devices

Submission Details

510(k) Number K040464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2004
Decision Date May 17, 2004
Days to Decision 84 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 87d · This submission: 84d
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 Toxicology devices follow this clearance model.

Regulatory Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K040464.
ON CALL MULTI-DRUG HOME TEST CUP
K050878 · ACON Laboratories, Inc. · Jun 2005
ON CALL MULTI-DRUG HOME TEST
K050050 · ACON Laboratories, Inc. · Mar 2005
RANDOX CANNABINOIDS ASSSAY
K041142 · Randox Laboratories, Ltd. · Nov 2004
ONLINE DAT II CANNABINOIDS II
K030213 · Roche Diagnostics Corp. · Apr 2003
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887 · Lin-Zhi International, Inc. · Aug 2002
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
K014066 · Princeton BioMeditech Corp. · Jun 2002