Cleared Traditional

K051579 - IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS

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

K051579 · Immunalysis Corporation · Toxicology device
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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

FDA 510(k) Submission Details - K051579

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.

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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 184
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K051579.
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · Dade Behring, Inc. · May 2006
QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
K051161 · Quest Diagnostics, Inc. · Nov 2005
SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS
K050394 · Medtox Diagnostics, Inc. · Oct 2005
RAPID READER
K041696 · American Bio Medica Corp. · Jul 2005
ON TRAK TESTCARD
K051235 · Varian, Inc. · Jun 2005
UCP RAPID DRUG SCREENING TESTS
K050540 · Ucp Biosciences, Inc. · Apr 2005