Cleared Traditional

K000461 - URINE CANNABINOIDS (THC) SCREEN FLEX RE...

K000461 is the FDA 510(k) clearance for URINE CANNABINOIDS (THC) SCREEN FLEX RE... by Dade Behring, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K000461 · Dade Behring, Inc. · Toxicology device
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Apr 2000
Decision
55d
Days
Class 2
Risk

K000461 is an FDA 510(k) clearance for the URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on April 6, 2000 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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

Submission Details

510(k) Number K000461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2000
Decision Date April 06, 2000
Days to Decision 55 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
32d faster than avg
Panel avg: 87d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 80
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K000461.
CANNABINOIDS
K013247 · Abbott Laboratories · Mar 2002
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164 · Roche Diagnostics Corp. · Apr 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131 · Phamatech · Feb 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · Syva Co. · Jan 2000
AT HOME DRUG TEST, MODEL 9078
K994220 · Phamatech · Dec 1999