Cleared Traditional

K982211 - PROFILE-II MODEL 600582

K982211 is the FDA 510(k) clearance for PROFILE-II MODEL 600582 by Medtox Diagnostics, Inc.. It is a Class 2 Toxicology device (product code DKE) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K982211 · Medtox Diagnostics, Inc. · Toxicology device
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Jul 1998
Decision
36d
Days
Class 2
Risk

K982211 is an FDA 510(k) clearance for the PROFILE-II MODEL 600582. Classified as Reagents, Test, Tetrahydrocannabinol (product code DKE), Class II - Special Controls.

Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on July 29, 1998 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 Medtox Diagnostics, Inc. devices

Submission Details

510(k) Number K982211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1998
Decision Date July 29, 1998
Days to Decision 36 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
51d faster than avg
Panel avg: 87d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKE Reagents, Test, Tetrahydrocannabinol
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKE Reagents, Test, Tetrahydrocannabinol

All 7
Devices cleared under the same product code (DKE) and FDA review panel - the closest regulatory comparables to K982211.
STATUS CUP ACCUSIGN CUP
K991751 · Princeton BioMeditech Corp. · Jun 1999
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
K991078 · Princeton BioMeditech Corp. · Apr 1999
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
K983147 · Princeton BioMeditech Corp. · Sep 1998
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182 · Marion Laboratories, Inc. · Jul 1988
TOXI-LAB CANNABINOID THC SCREEN
K831456 · Marion Laboratories, Inc. · Jun 1983