Cleared Traditional

K971109 - QUIKPAC II ONE STEP AMPHETAMINE TEST

K971109 is the FDA 510(k) clearance for QUIKPAC II ONE STEP AMPHETAMINE TEST by Drial Consultants, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K971109 · Drial Consultants, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
49d
Days
Class 2
Risk

K971109 is an FDA 510(k) clearance for the QUIKPAC II ONE STEP AMPHETAMINE TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Drial Consultants, Inc. (Simi Valley, US). The FDA issued a Cleared decision on May 14, 1997 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Drial Consultants, Inc. devices

Submission Details

510(k) Number K971109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1997
Decision Date May 14, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 87d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K971109.
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K962411 · Roche Diagnostic Systems, Inc. · Oct 1996
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K955934 · Biosite Incorporated · Feb 1996
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