KXS · Radioimmunoassay, Methaqualone
Clinical Toxicology · 21 CFR 862.3630 · Class 2
Overview
| Product Code | KXS |
|---|---|
| Device Name | Radioimmunoassay, Methaqualone |
| Regulation | 21 CFR 862.3630 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A methaqualone test system is a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. Measurements obtained by this device are used in the diagnosis and treatment of methaqualone use or overdose.
Classification Rationale
Class II (special controls). A methaqualone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Special Controls
*Classification.* Class II (special controls). A methaqualone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011164 | MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 | Syva Co., Dade Behring, Inc. | May 10, 2001 | SESE |
| K993986 | SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL | Syva Co. | Jan 27, 2000 | SESE |
| K955676 | SYNCHRON SYSTEMS METHAQUALONE REAGENT | Beckman Instruments, Inc. | Mar 4, 1996 | SESE |
| K945187 | ROCHE ABUSCREEN ONLINE FOR METHAQUALONE | Roche Diagnostic Systems, Inc. | Apr 5, 1995 | SESE |
| K940123 | METHAQUALONE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | May 3, 1994 | SESE |
| K921013 | SYVA EMIT II METHAQUALONE ASSAY | Syva Co. | May 13, 1992 | SESE |
| K874272 | REVISED LABELING FOR METHAQUALONE TEST KIT | Roche Diagnostic Systems, Inc. | Nov 13, 1987 | SESE |
| K874199 | REVISED LABELING FOR SYVA METHAQUALONE ASSAYS | Syva Co. | Oct 28, 1987 | SESE |
| K873759 | LABELING CHANGE COAT-A-COUNT METHAQUALONE | Diagnostic Products Corp. | Oct 15, 1987 | SESE |
| K870935 | COAT-A-COUNT METHAQUALONE TKMQ1 | Diagnostic Products Corp. | Mar 19, 1987 | SESE |
| K843605 | EMIT 700 METHAQUALONE ASSAY | Syva Co. | Oct 5, 1984 | SESE |
| K840164 | EMIT ST URINE METHAQUALONE ASSAY | Syva Co. | Mar 22, 1984 | SESE |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | Hoffmann-La Roche, Inc. | Mar 24, 1983 | SESE |
| K822051 | EMIT D.A.V. METHAQUALONE ASSAY | Syva Co. | Jul 27, 1982 | SESE |
| K821768 | EMIT ST URINE METHAGUALONE ASSAY | Syva Co. | Jun 24, 1982 | SESE |
| K812987 | AGGLUTEX METHAQUALONE TEST KIT | Hoffmann-La Roche, Inc. | Dec 22, 1981 | SESE |
Top Applicants
- Syva Co. — 7 clearances
- Diagnostic Products Corp. — 2 clearances
- Hoffmann-La Roche, Inc. — 2 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
- Beckman Instruments, Inc. — 1 clearance
