Cleared Traditional

K915516 - ABUSCREEN ONLINE CANNABINOIDS POSITIVE ...

K915516 is the FDA 510(k) clearance for ABUSCREEN ONLINE CANNABINOIDS POSITIVE ... by Roche Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code LAS) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K915516 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jan 1992
Decision
50d
Days
Class 1
Risk

K915516 is an FDA 510(k) clearance for the ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on January 28, 1992 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 K915516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date January 28, 1992
Days to Decision 50 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
37d faster than avg
Panel avg: 87d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LAS Drug Specific Control Materials

All 53
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K915516.
DUPONT ACA URINE METHADONE CONTROL
K934145 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
K921939 · Heraeus Kulzer, Inc. · Jul 1992
CANNABINOID URINE CONTROLS
K921141 · Diagnostic Reagents, Inc. · Apr 1992
ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
K913677 · Analytical Control Systems, Inc. · Sep 1991
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · Roche Diagnostic Systems, Inc. · Aug 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
K913107 · Roche Diagnostic Systems, Inc. · Aug 1991