Cleared Traditional

K950139 - DRUGS OF ABUSE CALIBRATOR

K950139 is the FDA 510(k) clearance for DRUGS OF ABUSE CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K950139 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
40d
Days
Class 2
Risk

K950139 is an FDA 510(k) clearance for the DRUGS OF ABUSE CALIBRATOR. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on February 22, 1995 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K950139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1995
Decision Date February 22, 1995
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DKB Calibrators, Drug Mixture

All 77
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K950139.
SERUM TOX CALIBRATOR
K961372 · Diagnostic Reagents, Inc. · May 1996
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
K954608 · Boehringer Mannheim Corp. · Dec 1995
EMIT IIC CALIBRATORS
K935192 · Syva Co. · Mar 1995
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
K945289 · Medi-Tech, Inc. · Dec 1994
ROCHE AMMONIA (VARIOUS)
K942048 · Roche Diagnostic Systems, Inc. · Oct 1994
URINE CALIBRATOR
K940935 · Diagnostic Reagents, Inc. · Jul 1994