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FDA Clears Siemens Healthineers Analyzer for Low- to Mid-Volume Labs

NEW YORK – Siemens Healthineers said Thursday that it has received US Food and Drug Administration clearance for an analyzer designed for immunoassay and clinical chemistry testing in low- to medium-volume laboratories.

The Atellica CI Analyzer, which has been sold in Europe as the Atellica CI 1900, uses the same reagents, consumables, and software as the company's flagship Atellica Solution instrument. Siemens plans to deliver a menu of more than 200 assays for 20 disease states. More than 50 key assays can deliver results in less than 14 minutes, the firm said. Siemens plans to adopt the Atellica CI Analzyer name for the instrument worldwide.

According to Siemens, the Atellica CI Analyzer's 1.9-square-meter footprint is also ideal for smaller laboratories. A spec sheet available from Siemens' website for the Atellica CI 1900 indicates the instrument provides throughput of up to 1,120 tests per hour.

The instrument incorporates random-access sampling, micro-volume aspiration, and automated maintenance and quality control scheduling, and it has the ability to generate reports used to help labs meet accreditation guidelines. Its chemistry and immunoassay functions operate independently, which can prevent simultaneous interruptions if a laboratory needs to halt one of those functions.

Sharon Bracken, head of diagnostics for Siemens Healthineers, said in a statement that the instrument helps provide the workflow standardization and clinical equivalence that are critical to laboratories in a healthcare network.

"Labs today need testing instrumentation and informatics that can easily keep pace with rapidly changing testing demands as they occur," she said. "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."

Siemens previously said that the launch of this instrument would complete the firm's immunoassay and clinical chemistry testing portfolio. The company is also cutting its legacy analyzer lineup to reduce costs and supply chain difficulties.