# K971506: Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jun 3, 1997 after 39 days
- Product code: DMT (Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet)
- Device class: 2
- Regulation: 21 CFR 862.3040
- 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 K923783 (1993). 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)
- K923783: Ethyl Alcohol Assay, Diagnostic Reagents, Inc. (1993) Summary page 1.

## Indications for use
The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.

Source page: https://510kreport.com/device/K971506
Methodology: https://510kreport.com/methodology