Cleared Traditional

ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 (K961620) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961620 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jun 1996
Decision
48d
Days
Class 2
Risk

K961620 is an FDA 510(k) clearance for the ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100. Classified as Radioimmunoassay, Cannabinoid(s) (product code LAT), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 48 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K961620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date June 13, 1996
Days to Decision 48 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 87d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAT Radioimmunoassay, Cannabinoid(s)
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 - LAT Radioimmunoassay, Cannabinoid(s)

All 15
Devices cleared under the same product code (LAT) and FDA review panel - the closest regulatory comparables to K961620.
DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE
K914507 · Diagnostic Products Corp. · Dec 1991
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
K913414 · Roche Diagnostic Systems, Inc. · Sep 1991
ABUSCREEN ONLINE FOR THC (50 AND 100)
K912574 · Roche Diagnostic Systems, Inc. · Aug 1991
ABUSCREEN ONLINE TM FOR THC
K904996 · Roche Diagnostic Systems, Inc. · Jan 1991
EMIT -D.A.U. CANNABINOID URINE ASSAY
K800246 · Syva Co. · Feb 1980