Cleared Special

K080872 - AMEDICHECK DRUG SCREEN THC

K080872 is the FDA 510(k) clearance for AMEDICHECK DRUG SCREEN THC by Amedica Biotech, Inc.. It is a Class 2 Chemistry device (product code LDJ) cleared through the Special 510(k) pathway after a 141-day FDA review.

K080872 · Amedica Biotech, Inc. · Chemistry device
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Aug 2008
Decision
141d
Days
Class 2
Risk

K080872 is an FDA 510(k) clearance for the AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ. 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 August 19, 2008 after a review of 141 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Amedica Biotech, Inc. devices

Submission Details

510(k) Number K080872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date August 19, 2008
Days to Decision 141 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 88d · This submission: 141d
Pathway characteristics
Modification to existing cleared device.

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 86
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