Cleared Traditional

K000851 - PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR

K000851 is an FDA 510(k) clearance for PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR, manufactured by Psychemedics Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K000851

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.

DJG Device Classification - Class 2, Special Controls

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 189
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K000851.
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
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
K011289 · Syva Co., Dade Behring, Inc. · May 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