# K141388: System Calibrater

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter Ireland, Inc.
- Decided: Jul 11, 2014 after 45 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 K951964 (1995). 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)
- K951964: Synchron Enzyme Validator Set, Beckman Instruments, Inc. (1995) Summary page 1.

## Indications for use
The System Calibrator is a calibration serum intended to be used for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH enzymes on Beckman Coulter AU450, AU650 and AU5800 analysers. For In Vitro Diagnostic use only.

Source page: https://510kreport.com/device/K141388
Methodology: https://510kreport.com/methodology