Cleared Traditional

K163590 - Psychemedics Microplate EIA for Benzodi...

K163590 is an FDA 510(k) clearance for Psychemedics Microplate EIA for Benzodi..., manufactured by Psychemedics Corporation. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K163590 · Psychemedics Corporation · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
269d
Days
Class 2
Risk

K163590 is an FDA 510(k) clearance for the Psychemedics Microplate EIA for Benzodiazepines in Hair. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on September 15, 2017 after a review of 269 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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 - K163590

510(k) Number K163590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2016
Decision Date September 15, 2017
Days to Decision 269 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
182d slower than avg
Panel avg: 87d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 76
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K163590.
ONLINE DAT Benzodiazepines II
K221765 · Roche Diagnostics · Dec 2022
CEDIA Benzodiazepine Assay
K190968 · Microgenics Corporation · Dec 2019
DRI Benzodiazepine Assay
K173963 · Microgenics Corporation · Feb 2018
Healgen Multi-Drug Urine Test Cup
K163704 · Healgen Scientific, LLC · Aug 2017
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K153597 · Healgen Scientific, LLC · May 2016
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K151771 · Immunalysis Corporation · Jan 2016