Cleared Traditional

K963606 - VISUALINE COMBO V (COCAINE/THC) TEST

K963606 is the FDA 510(k) clearance for VISUALINE COMBO V (COCAINE/THC) TEST by Sun Biomedical Laboratories, Inc.. It is a Class 2 Chemistry device (product code LDJ) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K963606 · Sun Biomedical Laboratories, Inc. · Chemistry device
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Oct 1996
Decision
51d
Days
Class 2
Risk

K963606 is an FDA 510(k) clearance for the VISUALINE COMBO V (COCAINE/THC) TEST. 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 October 30, 1996 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3870 - the FDA in vitro diagnostics and chemistry 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 Sun Biomedical Laboratories, Inc. devices

Submission Details

510(k) Number K963606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1996
Decision Date October 30, 1996
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K963606.
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122 · Phamatech · Sep 1997
ONE STEP MARIJUANA CARD TEST
K970548 · Teco Diagnostics · Jul 1997
IMMULITE CANNABINOIDS
K963916 · Diagnostic Products Corp. · Apr 1997
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