Cleared Traditional

K000851 - PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR

K000851 is the FDA 510(k) clearance for PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR by Psychemedics Corp.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K000851 · Psychemedics Corp. · Toxicology device
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Dec 2000
Decision
271d
Days
Class 2
Risk

K000851 is an FDA 510(k) clearance for the PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Psychemedics Corp. (Cambridge, US). The FDA issued a Cleared decision on December 11, 2000 after a review of 271 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 Corp. devices

Submission Details

510(k) Number K000851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2000
Decision Date December 11, 2000
Days to Decision 271 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
184d slower than avg
Panel avg: 87d · This submission: 271d
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 K000851.
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
K013380 · ACON Laboratories, Inc. · Dec 2001
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353 · ACON Laboratories, Inc. · Jul 2001
DRIDAU OPIATE ASSAY
K011150 · Microgenics Corp. · Jun 2001
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209 · Dade Behring, Inc. · Dec 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
K001178 · Microgenics Corp. · Jun 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
K000464 · Dade Behring, Inc. · Apr 2000