Cleared Traditional

K904115 - HYCOR ACCUPINCH METHAMPHETAMINE TEST

K904115 is the FDA 510(k) clearance for HYCOR ACCUPINCH METHAMPHETAMINE TEST by Hycor Biomedical, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K904115 · Hycor Biomedical, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
83d
Days
Class 2
Risk

K904115 is an FDA 510(k) clearance for the HYCOR ACCUPINCH METHAMPHETAMINE TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on November 28, 1990 after a review of 83 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 Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K904115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date November 28, 1990
Days to Decision 83 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
4d faster than avg
Panel avg: 87d · This submission: 83d
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 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K904115.
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
MILENIA (TM) METHAMPHETAMINE
K904451 · Diagnostic Products Corp. · Nov 1990
DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY
K903824 · Technicon Instruments Corp. · Sep 1990
MILENIA (TM) AMPHETAMINE
K902979 · Diagnostic Products Corp. · Sep 1990