Abbott lands FDA clearance of Alinity complete blood count system

Dive Brief:

Abbott has received U.S. Food and Drug Administration clearance for a diagnostic instrument that runs complete blood counts, the company announced on Monday.
The Alinity h-series system, which received a CE mark more than five years ago, pairs Abbott’s existing automated hematology analyzer and integrated slide maker and stainer. Abbott filed for 510(k) clearance at the start of 2022.
Abbott is pitching the device as using less floor space and having one of the highest throughputs as it competes with companies including Beckman Coulter and Siemens Healthineers for market share.

Dive Insight:

Complete blood counts are commonly ordered as part of routine checkups. By taking counts of white blood cells, red blood cells and platelets, measuring the concentration of hemoglobin and testing other aspects of the blood, the tests can detect infections, immune diseases, anemia and other conditions. Abbott and rivals such as Beckman, Healthineers and Sysmex sell a range of hematology analyzers.

Abbott’s Alinity h-series is the latest entrant to the U.S. market. Louis Morrone, executive vice president for Abbott’s core diagnostics business, said the hematology system aims to help U.S. labs as they face resource challenges.

“U.S. healthcare systems have experienced significant resource constraints and rapidly shifting dynamics post-pandemic,” Morrone said in a statement. “The Alinity h-series system, as with the entire suite of Alinity products, was developed to transform the way laboratories run tests so they can focus on their most important mission: the delivery of patient care.”

The system can process up to 119 complete blood count results per hour. When Abbott launched the machine in Europe in 2018, it said the device was 20% faster per square meter than other currently available integrated hematology systems. Abbott now sells the device as being “among the fastest on the market.”

The system slots into a portfolio of Alinity devices that includes products for clinical chemistry and immunoassay, molecular, transfusion and point-of-care testing.