Cleared Traditional

K940123 - METHAQUALONE ENZYME IMMUNOASSAY

K940123 is an FDA 510(k) clearance for METHAQUALONE ENZYME IMMUNOASSAY, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code KXS cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K940123 · Diagnostic Reagents, Inc. · Toxicology device
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May 1994
Decision
113d
Days
Class 2
Risk

K940123 is an FDA 510(k) clearance for the METHAQUALONE ENZYME IMMUNOASSAY. Classified as Radioimmunoassay, Methaqualone (product code KXS), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 3, 1994 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K940123

510(k) Number K940123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date May 03, 1994
Days to Decision 113 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
26d slower than avg
Panel avg: 87d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXS Device Classification - Class 2, Special Controls

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 K940123.
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