Cleared Traditional

K972059 - QUIKPAC II ONE STEP COCAINE TEST

K972059 is an FDA 510(k) clearance for QUIKPAC II ONE STEP COCAINE TEST, manufactured by Drial Consultants, Inc.. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K972059 · Drial Consultants, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
87d
Days
Class 2
Risk

K972059 is an FDA 510(k) clearance for the QUIKPAC II ONE STEP COCAINE TEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Drial Consultants, Inc. (Simi Valley, US). The FDA issued a Cleared decision on August 28, 1997 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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

FDA 510(k) Submission Details - K972059

510(k) Number K972059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date August 28, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 87d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIO Device Classification - Class 2, Special Controls

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 116
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K972059.
DRUG CHECK
K980153 · Texas Immunology, Inc. · Mar 1998
RAPID DRUG SCREEN' 8 PANEL
K980872 · American Bio Medica Corp. · Mar 1998
STC COCAINE METABOLITE MICRO-PLATE EIA
K973651 · OraSure Technologies, Inc. · Jan 1998
AQ ONE STEP COCAINE TEST
K972384 · Bionike Laboratories, Inc. · Aug 1997
QUIKSTRIP ONE STEP COCAINE TEST
K971926 · Drial Consultants, Inc. · Jul 1997
RAPID DRUG SCREEN
K964900 · American Bio Medica Corp. · Apr 1997