FDA clears Abbott Alinity h

August 7, 2023 By Sean Whooley

FDA clearance enables laboratories to run complete blood counts (CBCs) as part of Abbott’s Alinity family of diagnostic products. CBCs, among the most ordered tests in healthcare, help to screen for a variety of disorders. That includes infections, anemia, diseases of the immune system and blood cancers.

The Alinity h-series includes Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide maker and stainer. Abbott said Alinity hq’s key differentiator is the leveraging of advanced MAPSS technology. MAPSS uses light scattering to distinguish cellular features and better identify various blood cells.

Abbott says that bringing the Alinity h-series to market enables it to offer one of the broadest laboratory diagnostic systems available. It provides a wide array of tests that doctors can use to quickly and effectively care for their patients. Laboratories can seamlessly integrate the hematology system into their existing core lab operations, too, saving time and resources.

Alinity h-series processes up to 119 CBC results per hour and requires less floor space in the laboratory. It loads samples from the front and from a laboratory automation system and ensures urgent samples receive priority without compromising capacity or workflow.

Additionally, the system offers hands-off maintenance so labs can schedule automated daily and weekly cleanings. It integrates the slide maker with the analyzer to reduce manual intervention and provides customizable reports and rules. Alinity h-series also centralizes results and control functions at a single point.

The Alinity family now includes the Alinity h-series, Alinity ci, Alinity m, Alinity s and the point-of-care i-STAT Alinity.

“U.S. healthcare systems have experienced significant resource constraints and rapidly shifting dynamics post-pandemic,” said Louis Morrone, EVP for Abbott’s core diagnostics business. “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.”

Filed Under: Blood Management, Diagnostics, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Lab Instruments & Supplies, Regulatory/Compliance Tagged With: Abbott, FDA