# K970919: Synchron CX Systems Uric Acid (Uric) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 21, 1997 after 70 days
- Product code: KNK (Acid, Uric, Uricase (Colorimetric))
- Device class: 1
- Regulation: 21 CFR 862.1775
- 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 K881498 (1988). 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)
- K881498: Synchron CX (TM)4 Clinical Analyzer, Beckman Instruments, Inc. (1988) Summary page 1.
- (no number) Beckman SYNCHRON Systems Uric Acid (URIC) Reagent as used on the SYNCHRON CX Systems: named in the summary without a submission number

## Indications for use
The SYNCHRON Systems Uric Acid (URIC) Reagent, in conjunction with SYNCHRON MULTI™ Calibrator, is intended for use in the quantitative determination of uric acid in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.

Source page: https://510kreport.com/device/K970919
Methodology: https://510kreport.com/methodology