Cleared Traditional

K870197 - KDI QUIK TEST(TM) MARIJUANA SCREEN

K870197 is the FDA 510(k) clearance for KDI QUIK TEST(TM) MARIJUANA SCREEN by Keystone Diagnostics, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K870197 · Keystone Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
132d
Days
Class 2
Risk

K870197 is an FDA 510(k) clearance for the KDI QUIK TEST(TM) MARIJUANA SCREEN. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Keystone Diagnostics, Inc. (Washington, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 132 days - within the typical 510(k) review window.

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 Keystone Diagnostics, Inc. devices

Submission Details

510(k) Number K870197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1987
Decision Date June 01, 1987
Days to Decision 132 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 87d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K870197.
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS
K874156 · Syva Co. · Oct 1987
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE
K873753 · Diagnostic Products Corp. · Oct 1987
DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5
K871695 · Diagnostic Products Corp. · Jun 1987
ABUSCREEN (R) EIA CANNABINOIDS
K870377 · Roche Diagnostic Systems, Inc. · Mar 1987
TDXR CANNABINOIDS
K864751 · Abbott Laboratories · Mar 1987
EMIT D.A.U. CANNABINOID 20NG ASSAY
K860500 · Syva Co. · Apr 1986