Cleared Traditional

K905700 - EZ-SCREEN: AMPHETAMINES

K905700 is the FDA 510(k) clearance for EZ-SCREEN: AMPHETAMINES by Environmental Diagnostics, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K905700 · Environmental Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
26d
Days
Class 2
Risk

K905700 is an FDA 510(k) clearance for the EZ-SCREEN: AMPHETAMINES. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Environmental Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on January 15, 1991 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Environmental Diagnostics, Inc. devices

Submission Details

510(k) Number K905700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1990
Decision Date January 15, 1991
Days to Decision 26 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 87d · This submission: 26d
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K905700.
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
K910278 · Roche Diagnostic Systems, Inc. · Apr 1991
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
K910658 · Roche Diagnostic Systems, Inc. · Apr 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756 · Roche Diagnostic Systems, Inc. · Mar 1991
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
K903993 · Immunotech Corp. · Dec 1990
HYCOR ACCUPINCH METHAMPHETAMINE TEST
K904115 · Hycor Biomedical, Inc. · Nov 1990
MILENIA (TM) METHAMPHETAMINE
K904451 · Diagnostic Products Corp. · Nov 1990