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FDA Updates 510(k) Clearances for Becton Dickinson, Roche, BioMérieux in January

NEW YORK – The US Food and Drug Administration in January modified existing 510(k) clearances for several firms, including Becton Dickinson and Roche, while it granted new clearances for diagnostic instruments and assays from Medica, Selux Diagnostics, and others, according to the agency website.

Becton Dickinson got the OK from the agency to modify its portable immunoassay instrument for influenza A and B, the BD Veritor Plus Analyzer, to add the ability to transmit test results over a Wi-Fi network, integrate them into a data repository, and deliver them to a facility information system.

Roche got the nod for an update to its Elecsys Anti-HCV II immunoassay for detection of antibodies to the hepatitis C virus. The latest version has improved tolerance to biotin interference.

And BioMérieux received clearance for updates to its Vitek 2 AST-Gram Positive Moxifloxacin device to add breakpoint information for Staphylococcus spp. and Enterococcus faecalis.

Meanwhile, Bedford, Massachusetts-based Medica nabbed agency clearance for its EasyStat 300 analyzer system for quantitative measurements of partial pressure of oxygen, partial pressure of carbon dioxide, and hydrogen ion activity in blood samples. Those measurements are used to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.

Shanghai Genext Medical Technology also got the go-ahead for its Tacrolimus Assay Kit for the quantitative determination of the tacrolimus concentration in blood, which can help guide care of allograft patients who are receiving tacrolimus therapy. The China-based firm's particle-enhanced turbidimetric inhibition immunoassay is designed for use on the Beckman Coulter AU480 analyzer.

Last month, the FDA also cleared Selux's Next Generation Phenotyping System and the Selux Gram-Positive Panel for use on the system for antimicrobial susceptibility testing. The Boston-based company's Selux Gram-Positive Panel is an in vitro test to determine the susceptibility of isolated colonies of Staphylococcus and Enterococcus organisms to antimicrobial agents.