Cleared Traditional

ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (K830461) - FDA 510(k) Clearance

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

K830461 · Hoffmann-La Roche, Inc. · Toxicology device
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Mar 1983
Decision
37d
Days
Class 2
Risk

K830461 is an FDA 510(k) clearance for the ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE. Classified as Radioimmunoassay, Methaqualone (product code KXS), Class II - Special Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3630 - 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 K830461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date March 24, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 87d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXS Radioimmunoassay, Methaqualone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3630
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 - KXS Radioimmunoassay, Methaqualone

All 15
Devices cleared under the same product code (KXS) and FDA review panel - the closest regulatory comparables to K830461.
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986 · Syva Co. · Jan 2000
SYNCHRON SYSTEMS METHAQUALONE REAGENT
K955676 · Beckman Instruments, Inc. · Mar 1996
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
K945187 · Roche Diagnostic Systems, Inc. · Apr 1995
SYVA EMIT II METHAQUALONE ASSAY
K921013 · Syva Co. · May 1992
REVISED LABELING FOR METHAQUALONE TEST KIT
K874272 · Roche Diagnostic Systems, Inc. · Nov 1987
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
K874199 · Syva Co. · Oct 1987