Siemens Healthineers’ Atellica CI Analyzer Earns FDA Nod

Siemens Healthineers has achieved U.S. Food and Drug Administration (FDA) clearance for its Atellica CI analyzer for immunoassay and clinical chemistry testing.
 
The Atellica CI analyzer, according to the company, can improve turnaround time predictability, advanced reporting functionality, and focused safety and security measures. Both standalone labs and satellite labs of wider networks can have the same reagents, consumables, and intelligent software as Siemens’ flagship Atellica solution, condensed into a 1.9 square meter footprint.
 
“Workflow standardization and clinical equivalence are critical components of a successful laboratory operation within a health network. The Atellica CI Analyzer elevates laboratory operations to a new level of agility,” Sharon Bracken, head of Diagnostics for Siemens Healthineers, told the press. “Labs today need testing instrumentation and informatics that can easily keep pace with rapidly changing testing demands as they occur. This next-generation laboratory analyzer anticipates workflow bottlenecks, mitigates them proactively, and delivers insights based on data that help laboratory staff do their job more effectively and efficiently.”
 
CEO of Acibadem Labmed Clinic Laboratories and a Siemens Healthineers customer, Dr. Mustafa Serteser added, “For mid- or low-volume sized laboratories, the Atellica CI Analyzer is a best-in-class approach. Preservation of space in the lab, staff allocation per analyzer, turnaround time, and cost-effective usage of reagents are important and addressed with this analyzer.”
 
Atellica CI also features random access sampling, micro-volume aspiration, and automatic maintenance and quality control scheduling so labs can deliver more predictable sample turnaround times. Chemistry and immunoassay engines run independently so throughput isn’t compromised if one of the two needs to stop.
 
The Atellica CI analyzer comes equipped with the Atellica Laboratory Evaluation Suite to deliver inspection-ready reports. This helps labs meet accreditation guidelines without the need for additional software and lets laboratory staff refocus their time on other critical lab operations.
 
It has a planned menu of more than 200 assays across 20 disease states so each lab in a health network can choose the best tests for its patient population. More than 50 key assays can deliver results in under 14 minutes.