Cleared Traditional

K902979 - MILENIA (TM) AMPHETAMINE

K902979 is the FDA 510(k) clearance for MILENIA (TM) AMPHETAMINE by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code DKZ) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K902979 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
67d
Days
Class 2
Risk

K902979 is an FDA 510(k) clearance for the MILENIA (TM) AMPHETAMINE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on September 7, 1990 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - the FDA in vitro diagnostics and chemistry 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 K902979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1990
Decision Date September 07, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 88d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 114
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K902979.
HYCOR ACCUPINCH METHAMPHETAMINE TEST
K904115 · Hycor Biomedical, Inc. · Nov 1990
MILENIA (TM) METHAMPHETAMINE
K904451 · Diagnostic Products Corp. · Nov 1990
DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY
K903824 · Technicon Instruments Corp. · Sep 1990
EMIT D.A.U. AMPHETAMINE CLASS ASSAY
K900995 · Syva Co. · Apr 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · Roche Diagnostic Systems, Inc. · Mar 1990
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
K895210 · Abbott Laboratories · Sep 1989