Cleared Traditional

K082898 - AMEDICA DRUG SCREEN TEST CUP

K082898 is the FDA 510(k) clearance for AMEDICA DRUG SCREEN TEST CUP by Amedica Biotech, Inc.. It is a Class 2 Toxicology device (product code NGL) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K082898 · Amedica Biotech, Inc. · Toxicology device
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Dec 2008
Decision
80d
Days
Class 2
Risk

K082898 is an FDA 510(k) clearance for the AMEDICA DRUG SCREEN TEST CUP. Classified as Test, Opiates, Over The Counter (product code NGL), Class II - Special Controls.

Submitted by Amedica Biotech, Inc. (Hayward, US). The FDA issued a Cleared decision on December 19, 2008 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 Amedica Biotech, Inc. devices

Submission Details

510(k) Number K082898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date December 19, 2008
Days to Decision 80 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
7d faster than avg
Panel avg: 87d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGL Test, Opiates, Over The Counter
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 - NGL Test, Opiates, Over The Counter

All 21
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