Cleared Traditional

K901568 - MILENIA(TM) CANNABINOIDS

K901568 is the FDA 510(k) clearance for MILENIA(TM) CANNABINOIDS by Diagnostic Products Corp.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K901568 · Diagnostic Products Corp. · Toxicology device
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May 1990
Decision
43d
Days
Class 2
Risk

K901568 is an FDA 510(k) clearance for the MILENIA(TM) CANNABINOIDS. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 17, 1990 after a review of 43 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K901568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1990
Decision Date May 17, 1990
Days to Decision 43 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
44d faster than avg
Panel avg: 87d · This submission: 43d
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 80
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K901568.
EMIT(R) II CANNABINOID 50 NG ASSAY
K904571 · Syva Co. · Dec 1990
ABUSCREEN ONTRAK FOR THC
K904856 · Roche Diagnostic Systems, Inc. · Dec 1990
LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS
K904541 · Abbott Laboratories · Nov 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