# K103842: Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System Software Version 5.0

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 27, 2011 after 118 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883181 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042291: Unicel DXC 600 and 800 Synchron Systems, Beckman Coulter, Inc. (2004) Summary page 1.
- K060256: Unicel DXC 600I Synchron Access Clinical System, Beckman Coulter, Inc. (2006) Summary page 1.

## Recalls of this device
- Apr 22, 2014 · Class II · Z-2272-2016: Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
- Sep 3, 2012 · Class II · Z-0123-2013: Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle t
- Jul 6, 2012 · Class II · Z-0059-2013: The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial

## Indications for use
The UniCel DxC 800 System Software Version 5.0 is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of cleared clinical laboratory assays, such as glucose. GLUCm reagent is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, idiopathic hypoglycemnia, and pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K103842
Methodology: https://510kreport.com/methodology