FDA grants market authorization of ClearL Lab Reagents (T1, T2, B1, B2, M) to Beckman Coulter, Inc.to aid in the detection of leukemias and lymphomas.

The FDA has granted market authorization of ClearLLab Reagents (T1, T2, B1, B2, M) to Beckman Coulter, Inc. The allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M) makes this the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).

The FDA reviewed data for the ClearLLab test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. Its 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 compared the test�s results to alternative detection methods used by the clinical sites. The study showed that the results of the test aligned with the study site�s final diagnosis 93.4 percent of the time and correctly detected that there was a cancer presence (i.e., cancer abnormality) 84.2 percent of the time.

Along with this authorization, the FDA is establishing criteria, called special controls, which clarify the agency�s expectations in assuring the test�s accuracy, reliability and clinical relevance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for the ClearLLab Reagents and similar tests used to aid in the diagnosis of leukemias and lymphomas. The special controls also describe the least burdensome regulatory pathway for future developers of similar diagnostic tests for leukemias and lymphomas. Users of the new test are advised that results must be reviewed by a trained professional.