Cleared Traditional

K000466 - URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A

K000466 is an FDA 510(k) clearance for URINE METHADONE (METH) SCREEN FLEX REAG..., manufactured by Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code DJR cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K000466 · Dade Behring, Inc. · Toxicology device
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Apr 2000
Decision
54d
Days
Class 2
Risk

K000466 is an FDA 510(k) clearance for the URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on April 5, 2000 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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 - K000466

510(k) Number K000466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2000
Decision Date April 05, 2000
Days to Decision 54 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
33d faster than avg
Panel avg: 87d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJR Device Classification - Class 2, Special Controls

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 54
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K000466.
INSTANT-VIEW METHADONE URINE CASSETTE TEST
K010015 · Alfa Scientific Designs, Inc. · May 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
K010962 · Syva Co., Dade Behring, Inc. · Apr 2001
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
K002010 · OraSure Technologies, Inc. · Nov 2000
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · Syva Co. · Jan 2000
ACCUSIGN MTD, BIOSIGN MTD
K991080 · Princeton BioMeditech Corp. · Apr 1999
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153
K982938 · Phamatech · Feb 1999