Waters Corporation (NYSE: WAT) announced on November 10, 2026, that it has received 510(k) premarket clearance from the U.S. Food and Drug Administration (FDA). The clearance covers its CellStream multi-parameter flow cytometry reagent kit and automated software platform. The system is cleared for rapid clinical immunophenotypic classification of B-cell non-Hodgkin lymphoma. It is a global leader in analytical instruments and clinical diagnostic technologies.
FDA 510(k) Clearance Covers a Multiparameter Flow Cytometry Diagnostic Kit
The clearance expands Waters' footprint within clinical pathology and hospital diagnostic laboratories. Official FDA notification documents list the submission as K263198. The CellStream diagnostic kit uses a specialized 12-color fluorochrome-conjugated antibody formulation. The formulation targets key B-cell surface antigens.
The automated assay processes whole blood or bone marrow aspirates in less than 45 minutes. It analyzes cell morphology, light scatter, and fluorescent marker intensity to deliver standardized phenotypic profiles. Conventional manual multi-step staining protocols often require two to three days. The automated system reduces diagnostic turnaround times by more than 80 percent.
The Senior Vice President and President of Clinical Diagnostics at Waters Corporation stated from Milford, Massachusetts: "Receiving FDA 510(k) clearance underscores our ongoing commitment to advancing clinical oncology diagnostics. The CellStream platform provides hematopathologists with an automated, highly standardized solution that accelerates crucial diagnostic decision-making for critically ill lymphoma patients."
A Twelve-Color Fluorochrome Panel Delivers Rapid Turnaround and High Sensitivity
The CellStream system also demonstrates exceptional sensitivity in resolving complex immunophenotypic variations. It detects minimal residual disease (MRD). Extensive clinical validation studies demonstrated that the assay achieved over 99.2 percent diagnostic concordance across challenging B-cell subtypes. These subtypes include mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma.
The platform's proprietary spectral unmixing algorithm automatically compensates for optical overlap. It enables pathologists to identify aberrant clonal B-cell populations present at concentrations as low as one in one million leukocytes. This provides critical guidance for targeted therapeutics and CAR-T cell monitoring.
A professor of hematopathology and principal clinical investigator at Johns Hopkins Medicine commented: "In hematologic oncology, accurate phenotypic characterization directly dictates therapeutic selection. The automation and reproducibility delivered by Waters' new platform bring specialized reference-lab precision into community hospital settings."
Commercial Distribution Begins Across North American Medical Laboratories
Waters Corporation has initiated commercial production and distribution across North American reference laboratories and comprehensive cancer centers. The diagnostic kits are manufactured at Waters' certified GMP facility in Massachusetts. That facility features an automated freeze-drying formulation process. The process ensures ambient reagent stability for up to 18 months.
The design eliminates dependence on specialized cold-chain logistics. Waters has established commercial distribution partnerships with leading diagnostic providers, including Quest Diagnostics and LabCorp. The partnerships integrate CellStream into regional lab testing networks.
A managing partner at a Boston healthcare life sciences venture fund observed: "Clinical diagnostics is rapidly transitioning toward automated, high-complexity testing. By combining proprietary reagent chemistry with standardized algorithmic interpretation, Waters has established a formidable presence in the clinical lymphoma market."
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