# K032287: Modification to Synchron Systems Enzyme Validator Set Levels 1 and 2

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 18, 2003 after 25 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K984014 (1998). 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)
- K984014: Synchron Systems Enzyme Validator Set Levels 1 and 2, Beckman Coulter, Inc. (1998) Summary page 1.

## Indications for use
The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON@Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values are specific for the LIP chemistry on SYNCHRON Systems.

Source page: https://510kreport.com/device/K032287
Methodology: https://510kreport.com/methodology