Cleared Special

K011164 - MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229

K011164 is an FDA 510(k) clearance for MODIFICATION TO THE EMIT II PLUS METHAQ..., manufactured by Syva Co., Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code KXS cleared through the Special 510(k) pathway after a 24-day FDA review.

K011164 · Syva Co., Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
24d
Days
Class 2
Risk

K011164 is an FDA 510(k) clearance for the MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229. Classified as Radioimmunoassay, Methaqualone (product code KXS), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 10, 2001 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011164

510(k) Number K011164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2001
Decision Date May 10, 2001
Days to Decision 24 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 K011164.
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
METHAQUALONE ENZYME IMMUNOASSAY
K940123 · Diagnostic Reagents, Inc. · May 1994
SYVA EMIT II METHAQUALONE ASSAY
K921013 · Syva Co. · May 1992
REVISED LABELING FOR METHAQUALONE TEST KIT
K874272 · Roche Diagnostic Systems, Inc. · Nov 1987
K011164 · MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
Download PDF FDA Summary Syva Co., Dade Behrin…