Product Code: KXS FDA class 2 21 CFR 862.3630

Radioimmunoassay, Methaqualone

Clinical Toxicology

The Methaqualone Radioimmunoassay is an in vitro diagnostic device used to detect or quantify methaqualone, a sedative-hypnotic drug, in biological specimens such as urine or serum, primarily for forensic toxicology screening and clinical drug monitoring purposes. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KXS, regulated under 21 CFR 862.3630, in the Clinical Toxicology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: KXS
Device Class: FDA class 2
Regulation Number: 862.3630
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K011164	MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229	May 10, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K993986	SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL	Jan 27, 2000	Substantially Equivalent	Syva Co.
K955676	SYNCHRON SYSTEMS METHAQUALONE REAGENT	Mar 04, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K945187	ROCHE ABUSCREEN ONLINE FOR METHAQUALONE	Apr 05, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K940123	METHAQUALONE ENZYME IMMUNOASSAY	May 03, 1994	Substantially Equivalent	Diagnostic Reagents, Inc.
K921013	SYVA EMIT II METHAQUALONE ASSAY	May 13, 1992	Substantially Equivalent	Syva Co.
K874272	REVISED LABELING FOR METHAQUALONE TEST KIT	Nov 13, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K874199	REVISED LABELING FOR SYVA METHAQUALONE ASSAYS	Oct 28, 1987	Substantially Equivalent	Syva Co.
K873759	LABELING CHANGE COAT-A-COUNT METHAQUALONE	Oct 15, 1987	Substantially Equivalent	Diagnostic Products Corp.
K870935	COAT-A-COUNT METHAQUALONE TKMQ1	Mar 19, 1987	Substantially Equivalent	Diagnostic Products Corp.
K843605	EMIT 700 METHAQUALONE ASSAY	Oct 05, 1984	Substantially Equivalent	Syva Co.
K840164	EMIT ST URINE METHAQUALONE ASSAY	Mar 22, 1984	Substantially Equivalent	Syva Co.
K830461	ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE	Mar 24, 1983	Substantially Equivalent	Hoffmann-La Roche, Inc.
K822051	EMIT D.A.V. METHAQUALONE ASSAY	Jul 27, 1982	Substantially Equivalent	Syva Co.
K821768	EMIT ST URINE METHAGUALONE ASSAY	Jun 24, 1982	Substantially Equivalent	Syva Co.
K812987	AGGLUTEX METHAQUALONE TEST KIT	Dec 22, 1981	Substantially Equivalent	Hoffmann-La Roche, Inc.