Cleared Traditional

K111926 - PSYCHEMEDICS OPIATES EIA

K111926 is the FDA 510(k) clearance for PSYCHEMEDICS OPIATES EIA by Psychemedics Corp.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K111926 · Psychemedics Corp. · Toxicology device
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May 2012
Decision
300d
Days
Class 2
Risk

K111926 is an FDA 510(k) clearance for the PSYCHEMEDICS OPIATES EIA. Classified as Enzyme Immunoassay, Opiates (product code DJG), 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 862.3650 - 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 K111926 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
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.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 137
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