Cleared Traditional

K875182 - MODIFIED LABELING FOR TOXI-LAB THC SCREEN

K875182 is an FDA 510(k) clearance for MODIFIED LABELING FOR TOXI-LAB THC SCREEN, manufactured by Marion Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DKE cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K875182 · Marion Laboratories, Inc. · Toxicology device
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Jul 1988
Decision
201d
Days
Class 2
Risk

K875182 is an FDA 510(k) clearance for the MODIFIED LABELING FOR TOXI-LAB THC SCREEN. Classified as Reagents, Test, Tetrahydrocannabinol (product code DKE), Class II - Special Controls.

Submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on July 5, 1988 after a review of 201 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Marion Laboratories, Inc. devices

FDA 510(k) Submission Details - K875182

510(k) Number K875182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1987
Decision Date July 05, 1988
Days to Decision 201 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 87d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKE Device Classification - Class 2, Special Controls

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 8
Devices cleared under the same product code (DKE) and FDA review panel - the closest regulatory comparables to K875182.
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
PROFILE-II MODEL 600582
K982211 · Medtox Diagnostics, Inc. · Jul 1998
TOXI-LAB CANNABINOID THC SCREEN
K831456 · Marion Laboratories, Inc. · Jun 1983