Cleared Traditional

K992632 - IMMULITE AMPHETAMINE

K992632 is the FDA 510(k) clearance for IMMULITE AMPHETAMINE by Diagnostic Products Corp.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K992632 · Diagnostic Products Corp. · Toxicology device
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Jan 2000
Decision
174d
Days
Class 2
Risk

K992632 is an FDA 510(k) clearance for the IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 174 days - an extended review 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: 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K992632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1999
Decision Date January 27, 2000
Days to Decision 174 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 87d · This submission: 174d
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 114
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K992632.
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
K000606 · Beckman Coulter, Inc. · May 2000
CEDIA DAU AMPHASSURE ASSAY
K994380 · Microgenics Corp. · May 2000
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
K000460 · Dade Behring, Inc. · Apr 2000
AT HOME DRUG TEST, MODEL 9063
K994237 · Phamatech · Dec 1999
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
K990399 · Roche Diagnostics Corp. · Apr 1999
ONTRAK TESTCUP-ER M2K
K990418 · Roche Diagnostics Corp. · Apr 1999