Cleared Traditional

K130811 - PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE

K130811 is an FDA 510(k) clearance for PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE, manufactured by Psychemedics Corp.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K130811 · Psychemedics Corp. · Toxicology device
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May 2013
Decision
38d
Days
Class 2
Risk

K130811 is an FDA 510(k) clearance for the PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on May 2, 2013 after a review of 38 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 Psychemedics Corp. devices

FDA 510(k) Submission Details - K130811

510(k) Number K130811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2013
Decision Date May 02, 2013
Days to Decision 38 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
49d faster than avg
Panel avg: 87d · This submission: 38d
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
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