# K994169: Synchron CX Systems Prealbumin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 3, 2000 after 55 days
- Product code: JIS (Calibrator, Primary)
- 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: 2 generations back to K854811 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994168: Synchron LX Systems Prealbumin Calibrator, Beckman Coulter, Inc. (2000). Cleared while this submission was under review Summary page 1.
- K854811: Ics Pab Prealbumin Reagent Test Kit, Beckman Instruments, Inc. (1986) Summary page 1.

## Indications for use
The SYNCHRON® CX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman’s SYNCHRON CX Systems for the calibration of prealbumin test systems.

Source page: https://510kreport.com/device/K994169
Methodology: https://510kreport.com/methodology