Cleared Traditional

K874390 - CRACK-IT CANNABINOID SCREEN

K874390 is an FDA 510(k) clearance for CRACK-IT CANNABINOID SCREEN, manufactured by Sakers, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 531-day FDA review.

K874390 · Sakers, Inc. · Toxicology device
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Apr 1989
Decision
531d
Days
Class 2
Risk

K874390 is an FDA 510(k) clearance for the CRACK-IT CANNABINOID SCREEN. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Sakers, Inc. (Blackwood, US). The FDA issued a Cleared decision on April 10, 1989 after a review of 531 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Sakers, Inc. devices

FDA 510(k) Submission Details - K874390

510(k) Number K874390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1987
Decision Date April 10, 1989
Days to Decision 531 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
444d slower than avg
Panel avg: 87d · This submission: 531d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDJ Device Classification - Class 2, Special Controls

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 129
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K874390.
MILENIA(TM) CANNABINOIDS
K901568 · Diagnostic Products Corp. · May 1990
HYCOR ACCUPINCH THC TEST
K901334 · Hycor Biomedical, Inc. · May 1990
ADX CANNABINOIDS
K890693 · Abbott Laboratories · Aug 1989
ABUSCREEN FP FOR CANNABINOIDS
K890887 · Roche Diagnostic Systems, Inc. · Mar 1989
TDX CANNABINOIDS-GS
K883731 · Abbott Laboratories · Oct 1988
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
K882313 · Syva Co. · Aug 1988