Cleared Traditional

K961726 - ABUSCREEN ONLINE CANNABINOIDS CALIBRATI...

K961726 is the FDA 510(k) clearance for ABUSCREEN ONLINE CANNABINOIDS CALIBRATI... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K961726 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1996
Decision
69d
Days
Class 2
Risk

K961726 is an FDA 510(k) clearance for the ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on July 11, 1996 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 K961726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1996
Decision Date July 11, 1996
Days to Decision 69 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
18d faster than avg
Panel avg: 87d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DLJ Calibrators, Drug Specific

All 91
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K961726.
50NG/ML COCAINE METABOLITE CALIBRATOR
K972835 · Diagnostic Reagents, Inc. · Aug 1997
CEDIA DIGOXIN CALIBRATORS
K972433 · Boehringer Mannheim Corp. · Jul 1997
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
K962280 · Roche Diagnostic Systems, Inc. · Aug 1996
CEDIA DAU LSD CALBIRATORS
K955813 · Microgenics Corp. · Feb 1996
CEDIA DAU PPX/METH CALIBRATOR
K951153 · Microgenics Corp. · Apr 1995
THEOPHYLLINE CALIBRATORS
K945338 · Diagnostic Reagents, Inc. · Jan 1995