Cleared Traditional

K912756 - ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE ...

K912756 is the FDA 510(k) clearance for ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE ... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code KLN) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K912756 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1991
Decision
35d
Days
Class 2
Risk

K912756 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE. Classified as Radioimmunoassay, Cocaine Metabolite (product code KLN), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 K912756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1991
Decision Date July 26, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 87d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLN Radioimmunoassay, Cocaine Metabolite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - KLN Radioimmunoassay, Cocaine Metabolite

All 9
Devices cleared under the same product code (KLN) and FDA review panel - the closest regulatory comparables to K912756.
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)
K913867 · Immunalysis Corporation · Sep 1991
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
K913722 · Roche Diagnostic Systems, Inc. · Sep 1991
MILENIA COCAINE METABOLITE
K910044 · Diagnostic Products Corp. · Feb 1991
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
K905730 · Roche Diagnostic Systems, Inc. · Jan 1991
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
K904995 · Roche Diagnostic Systems, Inc. · Nov 1990
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
K871549 · Immunalysis Corporation · Jun 1987