Cleared Traditional

K950445 - VISUALINE II CANNABINOIDS (THC)

K950445 is an FDA 510(k) clearance for VISUALINE II CANNABINOIDS (THC), manufactured by Sun Biomedical Laboratories, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K950445 · Sun Biomedical Laboratories, Inc. · Toxicology device
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May 1995
Decision
95d
Days
Class 2
Risk

K950445 is an FDA 510(k) clearance for the VISUALINE II CANNABINOIDS (THC). Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Sun Biomedical Laboratories, Inc. (Cherry Hill, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sun Biomedical Laboratories, Inc. devices

FDA 510(k) Submission Details - K950445

510(k) Number K950445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1995
Decision Date May 02, 1995
Days to Decision 95 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 87d · This submission: 95d
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 124
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K950445.
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
K951853 · Tcpi, Inc. · Aug 1996
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677 · Beckman Instruments, Inc. · Apr 1996
FRONTLINE CANNABIS
K954497 · Boehringer Mannheim Corp. · Mar 1996
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1995
EMIT IIC CANNABINOID ASSAY
K940158 · Syva Co. · Feb 1995
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
K945550 · Princeton BioMeditech Corp. · Feb 1995