# K973069: Synchron Systems Methadone Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Sep 22, 1997 after 35 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- 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 K944074 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944074: CX (TM) Methadone (Metd) Reagent for Synchron CX Syst, Beckman Instruments, Inc. (1994). Our OCR of the scanned summary read K974074, FDA’s number for Infusion Dynamics Power Infuser (Infusion Dynamics, Inc.), decided Feb 17, 1998, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SYNCHRON Systems Methadone”.

## Indications for use
The Beckman SYNCHRON Systems Methadone Reagent, in conjunction with the SYNCHRON Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 ng/mL, on SYNCHRON Systems.

Source page: https://510kreport.com/device/K973069
Methodology: https://510kreport.com/methodology