Cleared Traditional

K010868 - PSYCHEMEDICS RIA COCAINE ASSAY (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010868 · Psychemedics Corp. · Toxicology device
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Nov 2001
Decision
228d
Days
Class 2
Risk

K010868 is an FDA 510(k) clearance for the PSYCHEMEDICS RIA COCAINE ASSAY. Classified as Radioimmunoassay, Cocaine Metabolite (product code KLN), Class II - Special Controls.

Submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on November 6, 2001 after a review of 228 days - an extended review cycle.

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

Submission Details

510(k) Number K010868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2001
Decision Date November 06, 2001
Days to Decision 228 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 87d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLN Radioimmunoassay, Cocaine Metabolite
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.