Cleared Traditional

K111925 - PSYCHEMEDICS COCAINE EIA

K111925 is an FDA 510(k) clearance for PSYCHEMEDICS COCAINE EIA, manufactured by Psychemedics Corp.. The device is a Class 2 Toxicology device with product code JXO cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K111925 · Psychemedics Corp. · Toxicology device
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May 2012
Decision
300d
Days
Class 2
Risk

K111925 is an FDA 510(k) clearance for the PSYCHEMEDICS COCAINE EIA. Classified as Enzyme Immunoassay, Cocaine (product code JXO), Class II - Special Controls.

Submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 Psychemedics Corp. devices

FDA 510(k) Submission Details - K111925

510(k) Number K111925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2011
Decision Date May 01, 2012
Days to Decision 300 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
213d slower than avg
Panel avg: 87d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXO Device Classification - Class 2, Special Controls

Product Code JXO Enzyme Immunoassay, Cocaine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - JXO Enzyme Immunoassay, Cocaine

Devices cleared under the same product code (JXO) and FDA review panel - the closest regulatory comparables to K111925.
Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
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STC DIAGNOSTICS BENZOYLECGONINE EIA
K915785 · Solarcare Technologies Corp,Inc. · Mar 1992
IL TEST(TM) COCAINE
K913737 · Instrumentation Laboratory CO · Dec 1991