# K050119: Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by Subtraction Kit

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 6, 2005 after 108 days
- Product code: JKM (Immunochemical, Bence-Jones Protein)
- Device class: 2
- Regulation: 21 CFR 866.5150
- 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 K802592 (1980). 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)
- K802592: Paragon Serum Protein Electrophoresis, Beckman Instruments, Inc. (1980) Summary page 2.
- K823884: Paragon Immunoelectrophoresis Reagent, Beckman Instruments, Inc. (1983) Summary page 2.

## Indications for use
The PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the electrophoretic separation of proteins in human urine. The PARAGON CZE® 2000 Urine Immunofixation by Subtraction (U-IFE/s) Electrophoresis Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the immunologic identification of monoclonal components in human urine.

Source page: https://510kreport.com/device/K050119
Methodology: https://510kreport.com/methodology