# K142346: Urine/CSF Albumin, Urine/CSF Albumin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter Ireland, Inc.
- Decided: Oct 15, 2014 after 54 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- 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 K964695 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082251: Synchron Systems Microalbumin (MA) Reagent, Model 475100, Beckman Coulter, Inc. (2009) Summary page 4.
- K964695: Immage Immunochemistry System Albumin (Alb) Reagent, Beckman Instruments, Inc. (1997) Summary page 4.
- K000331: Synchron LX Systems Microalbumin Calibrator, Beckman Coulter, Inc. (2000) Summary page 4.

## Indications for use
Urine/CSF Albumin: The Urine/CSF Albumin reagent is intended to be used for the quantitation of albumin concentration in human urine and cerebrospinal fluid (CSF) on the Beckman Coulter AU clinical chemistry systems as an aid in the diagnosis of kidney diseases. For in vitro diagnostic use only. Urine/CSF Albumin Calibrator: The Urine/CSF Albumin calibrator is intended to be used to calibrate the Urine/CSF Albumin reagent on the Beckman Coulter AU clinical chemistry systems. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K142346
Methodology: https://510kreport.com/methodology