Cleared Traditional

K011185 - PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY

K011185 is an FDA 510(k) clearance for PSYCHEMEDICS RIA METHAMPHETAMINE AND MD..., manufactured by Psychemedics Corp.. The device is a Class 2 Toxicology device with product code DJC cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K011185 · Psychemedics Corp. · Toxicology device
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Jan 2002
Decision
281d
Days
Class 2
Risk

K011185 is an FDA 510(k) clearance for the PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on January 24, 2002 after a review of 281 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 Corp. devices

FDA 510(k) Submission Details - K011185

510(k) Number K011185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2001
Decision Date January 24, 2002
Days to Decision 281 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
194d slower than avg
Panel avg: 87d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJC Device Classification - Class 2, Special Controls

Product Code DJC Thin Layer Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - DJC Thin Layer Chromatography, Methamphetamine

All 20
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