Cleared Traditional

K950136 - URINE OPIATES SCREEN FLEX(TM) REAGENT C...

K950136 is the FDA 510(k) clearance for URINE OPIATES SCREEN FLEX(TM) REAGENT C... by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K950136 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
82d
Days
Class 2
Risk

K950136 is an FDA 510(k) clearance for the URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 82 days - a notably fast clearance 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: 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 K950136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1995
Decision Date April 05, 1995
Days to Decision 82 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
5d faster than avg
Panel avg: 87d · This submission: 82d
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 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K950136.
CEDIA DAU OPIATE 2K ASSAY
K962795 · Boehringer Mannheim Corp. · Oct 1996
FRONTLINE OPIATES
K954498 · Boehringer Mannheim Corp. · Mar 1996
AXSYM OPIATES
K951287 · Abbott Laboratories · May 1995
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
K945608 · Princeton BioMeditech Corp. · Feb 1995
CEDIA DAU OPIATE ASSAY
K945343 · Microgenics Corp. · Jan 1995
CEDIA DAU OPIATE ASSAY
K941195 · Microgenics Corp. · Sep 1994