Cleared Traditional

K063015 - AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150

K063015 is an FDA 510(k) clearance for AMEDITECH IMMUTEST MULTI-DRUG SCREEN BU..., manufactured by Ameditech, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K063015 · Ameditech, Inc. · Toxicology device
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Dec 2006
Decision
79d
Days
Class 2
Risk

K063015 is an FDA 510(k) clearance for the AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Ameditech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 20, 2006 after a review of 79 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 Ameditech, Inc. devices

FDA 510(k) Submission Details - K063015

510(k) Number K063015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date December 20, 2006
Days to Decision 79 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
8d faster than avg
Panel avg: 87d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
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 - DJG Enzyme Immunoassay, Opiates

All 189
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