Cleared Traditional

K854009 - ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAM...

K854009 is the FDA 510(k) clearance for ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAM... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DJP) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K854009 · Roche Diagnostic Systems, Inc. · Toxicology device
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Oct 1985
Decision
15d
Days
Class 2
Risk

K854009 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP. Classified as Radioimmunoassay, Amphetamine (product code DJP), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Belleville, US). The FDA issued a Cleared decision on October 15, 1985 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 K854009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date October 15, 1985
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJP Radioimmunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DJP Radioimmunoassay, Amphetamine

All 8
Devices cleared under the same product code (DJP) and FDA review panel - the closest regulatory comparables to K854009.
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
K912755 · Roche Diagnostic Systems, Inc. · Aug 1991
REVISED DOUBLE ANTIBODY AMPHETAMINE
K882228 · Diagnostic Products Corp. · Aug 1988
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
K881817 · Roche Diagnostic Systems, Inc. · Jul 1988
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
K830482 · Hoffmann-La Roche, Inc. · Mar 1983
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
K823212 · Hoffmann-La Roche, Inc. · Nov 1982
AGGLUTEX AMPHETAMINE TEST KIT
K812986 · Hoffmann-La Roche, Inc. · Jan 1982