Cleared Traditional

K182103 - Psychemedics Microplate EIA for Fentany...

K182103 is an FDA 510(k) clearance for Psychemedics Microplate EIA for Fentany..., 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 258-day FDA review.

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

FDA 510(k) Submission Details - K182103

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.

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 149
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