Cleared Traditional

K201326 - Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair

K201326 is an FDA 510(k) clearance for Psychemedics Homogeneous Enzyme Immunoa..., manufactured by Psychemedics Corporation. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 434-day FDA review.

K201326 · Psychemedics Corporation · Toxicology device
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Optimized for regulatory review, auditing and printing
Jul 2021
Decision
434d
Days
Class 2
Risk

K201326 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psych.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on July 27, 2021 after a review of 434 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Psychemedics Corporation devices

FDA 510(k) Submission Details - K201326

510(k) Number K201326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2020
Decision Date July 27, 2021
Days to Decision 434 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
347d slower than avg
Panel avg: 87d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

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 204
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