Cleared Traditional

Psychemedics Microplate EIA for Fentanyl in Hair (K182103) - FDA 510(k) Clearance

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

K182103 · Psychemedics Corporation · Toxicology device
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Apr 2019
Decision
258d
Days
Class 2
Risk

K182103 is an FDA 510(k) clearance for the Psychemedics Microplate EIA for Fentanyl in Hair. 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 April 18, 2019 after a review of 258 days - an extended review cycle.

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 Corporation devices

Submission Details

510(k) Number K182103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2018
Decision Date April 18, 2019
Days to Decision 258 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
171d slower than avg
Panel avg: 87d · This submission: 258d
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 88
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K182103.
LZI Tramadol Enzyme Immunoassay
K201223 · Lin-Zhi International, Inc. · Jun 2020
ARK Fentanyl II Assay
K200197 · ARK Diagnostics, Inc. · Feb 2020
CEDIA Heroin Metabolite (6-AM) assay
K192943 · Microgenics Corporation · Dec 2019
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
K182123 · Advin Biotech, Inc. · Mar 2019
ARK Tramadol Assay
K182280 · ARK Diagnostics, Inc. · Dec 2018
LZI Fentanyl Enzyme Immunoassay
K181159 · Lin-Zhi International, Inc. · Dec 2018