July 19, 2017—Beckman Coulter Life Sciences received FDA regulatory clearance, through the de novo process, to market its ClearLLab reagents for in vitro diagnostic use. The ClearLLab reagents deliver the first preformulated IVD antibody cocktails for leukemia and lymphoma immunophenotyping in the clinical laboratory.
According to a June 29, 2017, news release from the FDA, the test “provides consistent results to aid in the diagnoses of these serious cancers.” The FDA evaluated data from a multisite clinical study that compared panel results to alternative detection methods.
The company is developing an advanced range of clinical flow systems to be launched during the next five years. ClearLLab is the first of this new generation of IVD systems, which are being developed to specifically address the diagnostic challenges and differing global workflow requirements of clinical laboratories.
ClearLLab delivers fast and accurate qualitative identification of various hematolymphoid cell populations by immunophenotyping on the FC500 flow cytometer. The premixed combinations aim to reduce manual error and validation time, accelerate sample preparation time, improve workflow, and streamline lab inventory management.