Cleared Traditional

K933279 - ABUSCREEN ONLINE BENZODIAZEPINES 300 CA...

K933279 is the FDA 510(k) clearance for ABUSCREEN ONLINE BENZODIAZEPINES 300 CA... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K933279 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1993
Decision
34d
Days
Class 2
Risk

K933279 is an FDA 510(k) clearance for the ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR. 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 August 9, 1993 after a review of 34 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 K933279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date August 09, 1993
Days to Decision 34 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
53d faster than avg
Panel avg: 87d · This submission: 34d
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 K933279.
CEDIA DAU THC CALIBRATORS
K935795 · Microgenics Corp. · Apr 1994
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
K932548 · Roche Diagnostic Systems, Inc. · Dec 1993
DUPONT ACA URINE METHADONE CALIBRATOR
K934144 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
URINE CALIBRATOR AND CONTROL
K931506 · Diagnostic Reagents, Inc. · Jul 1993
THC URINE CALIBRATORS
K923386 · Diagnostic Reagents, Inc. · Sep 1992
THC URINE CALIBRATORS
K920749 · Diagnostic Reagents, Inc. · Mar 1992