Cleared Traditional

K003209 - URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

K003209 is an FDA 510(k) clearance for URINE OPIATES (OPI) SCREEN FLEX REAGENT..., manufactured by Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K003209 · Dade Behring, Inc. · Toxicology device
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Dec 2000
Decision
53d
Days
Class 2
Risk

K003209 is an FDA 510(k) clearance for the URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on December 5, 2000 after a review of 53 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K003209

510(k) Number K003209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2000
Decision Date December 05, 2000
Days to Decision 53 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
34d faster than avg
Panel avg: 87d · This submission: 53d
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 188
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K003209.
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
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DRIDAU OPIATE ASSAY
K011150 · Microgenics Corp. · Jun 2001
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
K011289 · Syva Co., Dade Behring, Inc. · May 2001
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
RADID DRUG SCREEN 5-PANEL TEST
K993151 · American Bio Medica Corp. · Jan 2000