# K984014: Synchron Systems Enzyme Validator Set Levels 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 23, 1998 after 42 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SYNCHRON® Systems Enzyme Validator Set: named in the summary without a submission number

## Most influential descendants
- K032287: Modification to Synchron Systems Enzyme Validator Set Levels 1 and 2 (2003), 0 descendants of its own

## Recalls of this device
- Jul 29, 2004 · Not classified · Z-1378-04: incorrect Calibration Acceptance Limits.

## Indications for use
The SYNCHRON® Systems 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 for specific for the LIP chemistry on SYNCHRON Systems.

Source page: https://510kreport.com/device/K984014
Methodology: https://510kreport.com/methodology