Cleared Traditional

K000461 - URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A

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

K000461 · Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K000461

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.

LDJ Device Classification - Class 2, Special Controls

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 117
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K000461.
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RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)
K993961 · American Bio Medica Corp. · Jan 2000
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K993984 · Syva Co. · Jan 2000