Cleared Traditional

K051579 - IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL ...

K051579 is the FDA 510(k) clearance for IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL ... by Immunalysis Corporation. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K051579 · Immunalysis Corporation · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
129d
Days
Class 2
Risk

K051579 is an FDA 510(k) clearance for the IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on October 21, 2005 after a review of 129 days - within the typical 510(k) review window.

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

View all Immunalysis Corporation devices

Submission Details

510(k) Number K051579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2005
Decision Date October 21, 2005
Days to Decision 129 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 87d · This submission: 129d
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 K051579.
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
K063024 · Lin-Zhi International, Inc. · Oct 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · Dade Behring, Inc. · May 2006
EMIT II PLUS ECSTASY ASSAY
K043028 · Dade Behring, Inc. · Jan 2005
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
K041822 · ACON Laboratories, Inc. · Sep 2004
ACON TRI-FECT DRUG SCREEN TEST DEVICE
K041743 · ACON Laboratories, Inc. · Sep 2004