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# FDA OKs Marketing of Beckman Coulter’s ClearLLab Reagents
- URL: https://www.fdaweb.com/fda-oks-marketing-of-beckman-coulters-clearllab-reagents/
- Published: 2017-06-29T12:00:00.000Z
- Updated: 2026-09-14T22:32:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139068

FDA has allowed the marketing of Beckman Coulter’s ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in detecting several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome and myeloproliferative neoplasms. “Laboratories and health care professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers,” an [agency release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565321.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

The test is used to detect cancerous cells in blood, bone marrow and lymph nodes, and it also provides laboratories and clinicians with information about what type of leukemia or lymphoma is present. FDA says it works by marking proteins found on the surface of cells with fluorescent dyes for further analysis on an instrument known as a flow cytometer.

  
Its de novo marketing authorization was supported by a study designed to demonstrate the test’s performance, which was conducted on 279 samples at four, independent clinical sites. “The study showed that the results of the test aligned with the study site’s final diagnosis 93.4% of the time and correctly detected that there was a cancer presence (i.e., cancer abnormality) 84.2,” the agency says.