Cleared Traditional

K011426 - PSYCHEMEDICS RIA CANNABINOID ASSAY

K011426 is an FDA 510(k) clearance for PSYCHEMEDICS RIA CANNABINOID ASSAY, manufactured by Psychemedics Corp.. The device is a Class 2 Toxicology device with product code LAT cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K011426 · Psychemedics Corp. · Toxicology device
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May 2002
Decision
360d
Days
Class 2
Risk

K011426 is an FDA 510(k) clearance for the PSYCHEMEDICS RIA CANNABINOID ASSAY. Classified as Radioimmunoassay, Cannabinoid(s) (product code LAT), Class II - Special Controls.

Submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on May 3, 2002 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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. Elevated predicate reliance profile. 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 Corp. devices

FDA 510(k) Submission Details - K011426

510(k) Number K011426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2001
Decision Date May 03, 2002
Days to Decision 360 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
273d slower than avg
Panel avg: 87d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAT Device Classification - Class 2, Special Controls

Product Code LAT Radioimmunoassay, Cannabinoid(s)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LAT Radioimmunoassay, Cannabinoid(s)

All 15
Devices cleared under the same product code (LAT) and FDA review panel - the closest regulatory comparables to K011426.
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
K961620 · Roche Diagnostic Systems, Inc. · Jun 1996
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION
K936135 · Sudormed, Inc. · Jun 1996
DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE
K914507 · Diagnostic Products Corp. · Dec 1991
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
K913414 · Roche Diagnostic Systems, Inc. · Sep 1991
URINE THC DIRECT RIA KIT (I-125)
K913865 · Immunalysis Corporation · Sep 1991
ABUSCREEN ONLINE FOR THC (50 AND 100)
K912574 · Roche Diagnostic Systems, Inc. · Aug 1991