PR Newswire·Nov 10, 2026, 8:00 AM ET

Waters Achieves FDA 510(k) Clearance for Ready-to-Use Flow Cytometry Clinical Tests for Leukemia and Lymphoma

BD OneFlow™ LST and BD OneFlow™ B-CLPD T1 Tests received FDA 510(k) clearance in the U.S. on Nov. 10, 2026, for diagnosing B-cell non-Hodgkin lymphoma (NHL) & chronic lymphocytic leukemia (CLL).
The tests deliver 96.3% sensitivity & 98.2% specificity in identifying CLL.
The all-in-one solution reduces 95% of manual steps, improving workflow efficiency, turnaround times, & reducing errors.
Waters Corporation announced the clearance, enabling commercialization of this standardized, ready-to-use flow cytometry solution.
The BD OneFlow portfolio integrates reagents, instruments, protocols, & consumables to standardize immunophenotyping workflows.
An estimated 79,320 U.S. cases of NHL & 22,760 CLL cases are expected in 2026, with approximately 4,350 deaths.
The tests will be available for preorder & commercially available in the U.S. in spring 2027.
The broader BD OneFlow portfolio is built on validation work from the EuroFlow™ Consortium.