Cleared Traditional

K903993 - MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT

K903993 is an FDA 510(k) clearance for MICROZYME(TM) METHAMPHET/AMPHET ENZYME ..., manufactured by Immunotech Corp.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K903993 · Immunotech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
113d
Days
Class 2
Risk

K903993 is an FDA 510(k) clearance for the MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on December 20, 1990 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunotech Corp. devices

FDA 510(k) Submission Details - K903993

510(k) Number K903993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date December 20, 1990
Days to Decision 113 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
25d slower than avg
Panel avg: 88d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

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 186
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K903993.
TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)
K910739 · V-Tech, Inc. · Mar 1991
TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)
K910738 · V-Tech, Inc. · Mar 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756 · Roche Diagnostic Systems, Inc. · Mar 1991
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