/PRNewswire/ -- Beckman Coulter Diagnostics, a clinical diagnostics leader, today announced that the new DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer, received 510(k) clearance from the U.S. Food and Drug Administration. The DxC 500i combines advanced technology with an intuitive user interface, ensuring that laboratories of all sizes can meet the growing demands of modern healthcare.

/PRNewswire/ -- 临床诊断领域的领导者贝克曼库尔特诊断公司今日宣布，其新型 DxC 500i 临床分析仪已获得美国食品药品监督管理局 (FDA) 的 510(k) 认证。DxC 500i 是一款集临床化学和免疫分析于一体的分析仪，结合了先进技术与直观的用户界面，确保各种规模的实验室都能够满足现代医疗不断增长的需求。

With throughput of up to 800 clinical chemistry tests per hour and 100 immunoassay tests per hour, this analyzer delivers precise and reliable results critical for timely clinical decision-making..

每小时可完成多达 800 次临床化学测试和 100 次免疫测定测试，这款分析仪可提供及时的临床决策所必需的精准可靠的结果。

The new DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer, received 510(k) clearance from the U.S. Food and Drug Administration.

新型DxC 500i临床分析仪，一种集临床化学和免疫测定于一体的分析仪，获得了美国食品药品监督管理局（FDA）的510(k)许可。

Healthcare systems around the world and specifically in

世界各国的医疗系统，尤其是

the United States

美国

are strategically adopting networked laboratory operational models for better efficiency and patient access. Approximately 45% of clinical laboratories in

正在战略性地采用网络化实验室运营模式，以提高效率和患者获取途径。大约45%的临床实验室在

the United States

美国

— a total of more than 11,000 labs — are associated with an Integrated Delivery Network (IDN).

- 总计超过11,000个实验室 - 与综合交付网络 (IDN) 相关联。

IDNs are organizations that provide a coordinated range of healthcare services, including diagnostic testing allowing for better resource management, standardized practices, and enhanced quality of care.

整合型医疗网络（IDN）是提供一系列协调医疗服务的机构，包括诊断测试，以便更好地管理资源、实施标准化操作并提高护理质量。

'Innovations like the DxC 500i Clinical Analyzer enable Beckman Coulter to address the needs of networked laboratories with specific solutions for satellite or independent laboratories, as well as core laboratories,' said

“像DxC 500i临床分析仪这样的创新使贝克曼库尔特能够通过针对卫星实验室、独立实验室以及核心实验室的特定解决方案，满足网络化实验室的需求，”

Kathleen Orland

凯瑟琳·奥兰多

, Chief Portfolio Officer for Beckman Coulter Diagnostics. 'Beyond ensuring appropriate throughput levels for a networked lab, Beckman Coulter's common reagents and consumables across its scalable clinical chemistry and immunoassay portfolio enables common reference ranges, offering IDNs strategic benefits in patient care and inventory management.'.

贝克曼库尔特诊断公司的首席产品组合官表示：“除了确保联网实验室的适当通量水平外，贝克曼库尔特在其可扩展的临床化学和免疫测定产品组合中使用通用试剂和耗材，能够实现统一的参考范围，为综合交付网络（IDNs）在患者护理和库存管理方面提供战略优势。”

The DxC 500i Clinical Analyzer features FlexMode operations, prioritizing immunoassay and chemistry testing according to each sample's urgency. The new dynamic sample handler manages repeats and re-runs without operator intervention and pulls in a new sample rack as soon as the previous rack is offloaded, optimizing rapid throughput in a compact footprint.

DxC 500i临床分析仪具有FlexMode操作功能，能够根据每个样本的紧急程度优先进行免疫测定和化学检测。全新的动态样本处理器无需操作员干预即可管理重复和重新运行，并在前一个样本架卸载后立即拉入新的样本架，从而在紧凑的空间内优化快速通量。

Of equal importance, the DxC 500i Analyzer's intuitive interface supports even the newest users through proactive task indicators with step-by-step instructions, simplifying staff onboarding and training..

同样重要的是，DxC 500i分析仪的直观界面通过主动任务指示器和逐步指导，即使是最新用户也能轻松上手，从而简化员工入职和培训流程。

The DxC 500i Clinical Analyzer has been available in countries accepting CE mark since

DxC 500i临床分析仪已在接受CE标志的国家上市。

July 2024

2024年7月

Prior to the DxC 500i Clinical Analyzer introduction, Beckman Coulter unveiled the DxC 500 AU Chemistry Analyzer, an automated clinical chemistry analyzer with onboard guided workflows, more than 120 assays, and standardized reagents for use across healthcare networks. The DxC 500i analyzer incorporates the DxC 500 AU technology within its clinical chemistry capabilities, including its Six Sigma performance..

在DxC 500i临床分析仪推出之前，贝克曼库尔特发布了DxC 500 AU化学分析仪，这是一款具有机载引导工作流程、超过120种检测项目以及适用于医疗网络的标准化试剂的自动化临床化学分析仪。DxC 500i分析仪在其临床化学功能中融入了DxC 500 AU技术，包括其六西格玛性能。

Not all products are available in all countries. Product availability and regulatory status depends on country registration per applicable regulations.

并非所有产品都在所有国家/地区提供。产品的可用性与监管状态取决于根据适用法规的国家/地区注册情况。

Follow and connect with Beckman Coulter Diagnostics via

通过以下方式关注并与贝克曼库尔特诊断联系

About Beckman Coulter Diagnostics

贝克曼库尔特诊断公司简介

A global leader in advanced diagnostics,

全球先进的诊断技术领导者，

Beckman Coulter

贝克曼库尔特

has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our mission is to

挑战常规，提升诊断实验室在改善患者健康方面的作用已超过90年。我们的使命是

Relentlessly Reimagine Healthcare, One Diagnosis at a Time

不断重新构想医疗保健，一次一个诊断

— and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next.

——我们通过运用科学技术的力量以及团队的热情和创造力来实现这一目标。我们的诊断解决方案被用于复杂的临床测试中，遍布全球的医院、参考实验室和医生办公室。我们的使命是提供更智能、更快速的诊断解决方案，推动从现在到未来的进步。

We seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and to optimize lab performance services. Headquartered in .

我们致力于通过广泛的临床检测项目、可扩展的实验室自动化技术、富有洞察力的临床信息学以及优化的实验室性能服务来加速医疗服务。总部位于。