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FDA Grants 510(k) Clearances to Beckman Coulter, BioMérieux, Siemens Healthineers, Others in April

NEW YORK – It wasn't all about COVID-19 tests.

Amid issuing Emergency Use Authorizations for tests to diagnose COVID-19, the US Food and Drug Administration also cleared a number of in vitro diagnostic tests and systems in April, including those from Danaher's Beckman Coulter, BioMérieux, Siemens Healthineers, Sekisui Diagnostics, and others, according to the agency's website.

Beckman Coulter got the go-ahead for its Unicel DxH 800 Coulter Cellular Analysis System and the Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application. The UniCel DxH 800 Analyzer is an automated hematology analyzer used for screening patient populations. It identifies and enumerates multiple clinical parameters and measures monocyte distribution width from a whole-blood venous sample within two hours of collection.

BioMérieux nabbed clearance for its Vitek AST-Gram Positive Delafloxacin system for antimicrobial susceptibility testing of Gram-positive microorganisms. The test is used with the company's Vitek 2 and Vitek 2 Compact Systems. Delafloxacin (Melinta, Baxdela), an antibiotic, is active against multiple microorganism strains.

Sekisui Diagnostics got the nod for its Osom Ultra Plus Flu A&B test, a rapid immunochromatographic assay for the detection of influenza types A and B nucleoprotein antigens from swab specimens taken from patients with symptoms of respiratory infection. A negative test result is presumptive and should be confirmed by viral culture or by an FDA-cleared influenza A and B molecular assay, the agency said.

Maine Molecular Quality Controls received 510(k) clearance for BioMérieux's BioFire FilmArray BCID2 Control Panel M416, an external positive and negative assayed quality control to monitor the performance of nucleic acid testing procedures to detect certain antimicrobial resistance genes. The FilmArray BCID2 Control Panel M416 control is composed of synthetic DNA specifically designed for use with the BioFire BCID2 Panel assay.

The FDA granted clearance for use of the Siemens Healthineers Advia Centaur CA 125 II Assay to detect CA 125 and help in the management of patients with ovarian carcinoma. The assay runs on the firm's Advia Centaur XP and ADVIA Centaur XPT systems.

In April, the agency also cleared Abbott Laboratories' Blue i-Stat CG4+ cartridge, and Binx Health got the nod for the Binx io molecular point-of-care platform for the detection of chlamydia and gonorrhea in male urine specimens.