Cleared Traditional

AGGLUTEX AMPHETAMINE TEST KIT (K812986) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812986 · Hoffmann-La Roche, Inc. · Toxicology device
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Jan 1982
Decision
88d
Days
Class 2
Risk

K812986 is an FDA 510(k) clearance for the AGGLUTEX AMPHETAMINE TEST KIT. Classified as Radioimmunoassay, Amphetamine (product code DJP), Class II - Special Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982 after a review of 88 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 Hoffmann-La Roche, Inc. devices

Submission Details

510(k) Number K812986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1981
Decision Date January 22, 1982
Days to Decision 88 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 87d · This submission: 88d
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 K812986.
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 FOR AMPHETAMINE-HIGH SP
K854009 · Roche Diagnostic Systems, Inc. · Oct 1985