# K955676: Synchron Systems Methaqualone Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Mar 4, 1996 after 80 days
- Product code: KXS (Radioimmunoassay, Methaqualone)
- Device class: 2
- Regulation: 21 CFR 862.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921013 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921013: Syva Emit II Methaqualone Assay, Syva Co. (1992) Summary page 1.
- K940123: Methaqualone Enzyme Immunoassay, Diagnostic Reagents, Inc. (1994) Summary page 1.
- K935101: Urine Calibrators and Controls Modification, Diagnostic Reagents, Inc. (1994) Summary page 1.

## Indications for use
The SYNCHRON Systems Methaqualone Reagent, in conjunction with the SYNCHRON System DAT Urine Calibrators, is intended for use in the qualitative determination of Methaqualone in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

Source page: https://510kreport.com/device/K955676
Methodology: https://510kreport.com/methodology