Cleared Traditional

K123799 - PSYCHEMEDICS MICROPLATE EIA FOR OXYCODO...

K123799 is the FDA 510(k) clearance for PSYCHEMEDICS MICROPLATE EIA FOR OXYCODO... by Psychemedics Corp.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K123799 · Psychemedics Corp. · Toxicology device
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Feb 2013
Decision
60d
Days
Class 2
Risk

K123799 is an FDA 510(k) clearance for the PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR. 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 February 8, 2013 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Psychemedics Corp. devices

Submission Details

510(k) Number K123799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2012
Decision Date February 08, 2013
Days to Decision 60 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
27d faster than avg
Panel avg: 87d · This submission: 60d
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
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K123799.
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · Immunalysis Corporation · Jan 2014
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
K130665 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2013
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
K130055 · Guangzhou Wondfo Biotech Co., Ltd. · Feb 2013
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
K120763 · Lin-Zhi International, Inc. · Jun 2012
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
K120761 · Lin-Zhi International, Inc. · May 2012
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
K113624 · Guangzhou Wondfo Biotech Co., Ltd. · Mar 2012